Clinical Research Directory

SDT-Based Intervention for Exercise Motivation in Female Students

Physical inactivity, maladaptive exercise motives, and body image concerns are highly prevalent among young adult women and are associated with reduced psychological well-being and increased risk for disordered eating. This study protocol describes a randomized controlled trial designed to evaluate a multi-component psychoeducational intervention integrating Self-Determination Theory principles with functionality-oriented body image strategies to enhance autonomous motivation for exercise and promote psychological well-being among female university students. Female Health Sciences students aged 18-25 will be randomly allocated (1:1) to an experimental or control group following baseline assessment, and outcomes will be evaluated at baseline, post-intervention, and six-week follow-up. The six-session face-to-face intervention incorporates autonomy-supportive communication, competence-building activities, meaningful rationales, choice provision, and supportive relational climates, combined with functionality-based body image content. The primary outcome is autonomous motivation for exercise (BREQ-3; Relative Autonomy Index), and secondary outcomes include basic psychological need satisfaction and frustration, physical activity levels, positive body image, and eating disorder risk. Linear mixed-effects models will be used under an intention-to-treat approach, and mediation analyses will test whether changes in psychological need satisfaction underlie improvements in motivational quality. The intervention is expected to promote healthier motivational regulation, increase physical activity engagement, strengthen positive body image, and reduce maladaptive exercise drivers. Findings aim to inform scalable, theory-driven preventive strategies for improving health and well-being among young women in university settings.

Effects of Stoma Education on Patients

tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall is called a urostomy. Stomas are commonly used in the treatment of gastrointestinal diseases. Ileostomy and colostomy are the most frequently encountered types of stomas. While colorectal cancer is the primary reason for intestinal stoma creation, inflammatory bowel diseases, penetrating abdominal injuries, congenital anomalies, obstructions due to diverticular disease, ischemic colitis, radiation injury, sigmoid colon volvulus, and fecal incontinence are also among the indications for stoma creation. Despite advances in surgical techniques, complications are commonly seen in individuals with stomas. Incorrect stoma placement, the use of inappropriate bags and adapter systems, and a lack of knowledge and skills among patients and caregivers play a significant role in the development of complications. Depending on these conditions, patients may encounter problems such as edema, bleeding, ischemia, and mucocutaneous dehiscence in the early postoperative period. These complications negatively affect not only physical health but also the individual's social life, psychological state, and overall quality of life. Symptoms such as peristomal skin problems, uncontrolled gas release, fecal incontinence, and pain can hinder participants' adaptation to daily life and lead to social isolation. Nursing care and patient education are of great importance in managing these problems faced by individuals with stomas. The nursing process requires a comprehensive approach extending from the pre-operative period to the post-discharge phase. In this process, individualized education programs addressing fundamental issues such as nutrition, elimination, sexuality, social participation, and privacy should be implemented to improve quality of life, develop self-care skills, and prevent complications. In this context, the investigators have planned this study to determine the effects of the education provided to patients on stoma adaptation, body image, and self-efficacy.

MBSR Effects on Aging Anxiety and Body Image

This study was designed to determine the effect of a mindfulness-based stress reduction (MBSR) program on aging anxiety and body image among middle-aged women. The primary hypotheses to be tested are as follows: H0a: There is no difference in the mean scores of the Aging Anxiety Scale between the women in the experimental group who receive the mindfulness-based stress reduction program and the women in the control group. H0b: There is no difference in the mean scores of the Body Image Scale between the women in the experimental group who receive the mindfulness-based stress reduction program and the women in the control group. H0c: There is no difference between the pre-intervention and post-intervention mean scores of the Aging Anxiety Scale among the women in the experimental group who receive the mindfulness-based stress reduction program. H0d: There is no difference between the pre-intervention and post-intervention mean scores of the Body Image Scale among the women in the experimental group who receive the mindfulness-based stress reduction program. The researchers will compare the experimental group with the control group in order to assess the effect of the mindfulness-based stress reduction program on aging anxiety and body image among middle-aged women. Participants: * They will attend an 8-session mindfulness-based stress reduction program. * They will participate in one silent mindfulness retreat session.

Implementing an Eating Disorder Prevention Program for Youth in Nova Scotia

The goal of this study is to evaluate the Body Project, which is an eating disorder prevention program for youth 15-22 years old. The main question it aims to answer is 'Can an eating disorder prevention program, specifically the Body Project, be successfully delivered to youth in Nova Scotia'? This study will determine the feasibility of implementing the Body Project in Nova Scotia by assessing the following objectives: 1. Acceptability (how well the Body Project is received by, and the extent to which it is perceived as meeting the needs of, youth in Nova Scotia). 2. Demand (the extent to which youth in Nova Scotia are interested in and willing to engage with the program). 3. Integration (the extent to which the Body Project is judged as feasible by the group facilitators). 4. Effectiveness (the extent to which the Body Project reduces eating disorder risk factors in youth in Nova Scotia). Participants will: * Attend a total of 4-4.5 hours of Body Project group sessions, which are led by peer mentors. * Complete outcome measure questionnaires before their first session and after their last session. * Participate in a focus group with their session group members after their last session.

Effect of Skin Closure Techniques on Body Image in Women Undergoing Gynecologic Surgery

This randomized clinical trial investigates the impact of two different skin closure techniques on body image and mood in women undergoing surgery for gynecologic cancers. Patients undergoing elective surgery with a midline abdominal incision will be randomly assigned to one of two groups: 1. Interrupted Closure Group: The surgical incision is closed using either metal clips (staples) or separate mattress sutures (individual stitches). 2. Subcuticular Sutures Group: The surgical incision is closed using continuous stitches placed under the skin surface (aesthetic stitching). The main goal of the study is to determine whether the method of wound closure affects a patient's perception of their body image, cosmetic satisfaction, and levels of anxiety or depression. Additionally, the study aims to prove that the subcuticular suture technique is safe and does not increase the risk of wound complications (such as infection or wound separation) compared to the other method. Participants will be asked to complete questionnaires before surgery, and again at 1, 3 and 6 months after surgery to track changes in their feelings and satisfaction with the scar.

Virtual Body Project Groups Led by Peers Versus Clinicians

Eating disorders (EDs) are a group of illnesses associated with significant psychological and physiological consequences. Overall, only 20% of individuals with EDs receive treatment and treatment is effective for only about 25-35% for those who receive care. The development and implementation of effective prevention approaches for those at risk is therefore pivotal. The Body Project is the most effective ED prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. Further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. With this application, the investigators therefore propose to examine the effectiveness of the Body Project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered Body Project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).

Testing SHAPE: A Single-Session Intervention Targeting Binge Eating in Women Through Assessment and Values-Based Strategies

The goal of this controlled trial is to learn whether a brief single-session intervention (SSI) can reduce binge eating symptoms by targeting overvaluation of weight/shape in women with recurrent binge eating. The main questions it aims to answer are: * Does assessment alone reduce binge eating severity and overvaluation of weight/shape compared to a control group undergoing minimal assessment? * Does adding a values-based reflection and goal-setting component (the full SHAPE intervention) add benefits beyond the assessment alone? Researchers will compare three groups: 1. assessment-only, 2. full SHAPE intervention, and 3. minimal assessment control to see if both active conditions outperform the control, and whether the full intervention adds any benefits beyond the assessment itself Participants will: * Complete a semi-structured eating disorder assessment (Eating Disorder Examination) * Depending on assignment, also complete a values-based reflection and goal-setting exercise with psychoeducation * Complete follow-up assessments evaluating binge eating severity, overvaluation of weight/shape, clinical impairment, binge frequency, and related outcomes.

Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT

In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). HNC survivors will complete IMAGE-HN (a validated patient-reported outcome measure \[PROM\] of HNC-related body image distress \[BID\]; primary endpoint), measures of psychological and social well-being and quality of life (QOL), and measures of theory-derived mechanisms of change underlying BRIGHT (mediators).

The Impact of a Podcast-based Body Image Intervention Among Millennial Women

The goal of this three-arm randomized controlled trial is to evaluate the acceptability and efficacy of two podcast-based interventions -- a podcast with an accompanying journal and the same podcast without a journal -- which aim to improve body confidence among millennial-aged women (29-44 years of age) in the United Kingdom. A total of 1800 women in the UK (29-44 years), who are podcast listeners, will be recruited by a research agency. Participants will be randomised to one of three groups: body confidence podcast episode with journal; body confidence podcast episode alone; a non-body confidence-related podcast episode from the same series as the intervention podcast. The research aims are to determine the following: 1. Are the two versions of the intervention (i.e., podcast with and without a journal) effective in improving appearance esteem (primary outcome), internalisation of appearance ideals, self-objectification, and weight esteem among UK-based women (i) 1 day post-intervention and (ii) 1 week post-intervention, compared to a control podcast? 2. Are the two interventions (i.e., podcast with and without a journal) effective in generating immediate change in state body satisfaction and state mood, compared to a control podcast? 3. Are the two versions of the intervention acceptable to women?

WISH, Feasibility of a Factorial Design

The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.

Non-Diet Nutrition Education and Its Effects on Eating Behavior, Body Image, and Well-Being in Adult Women

The goal of this clinical trial is to evaluate whether a non-diet nutrition education program can improve eating behaviors, body image, and well-being in normal-BMI women aged 19-35 years. The main questions it aims to answer are: * Does participation in an 8-week non-diet nutrition education program improve eating behavior, body image, and well-being over time in the intervention group compared to the control group? * Is there a significant difference between the intervention and control groups in eating behavior, body image, and well-being after the intervention? Researchers will compare an intervention group receiving an 8-week non-diet nutrition education with a control group receiving no intervention, to see if the program leads to improvements in psychological and behavioral outcomes without focusing on weight loss. Participants will: * Complete pre- and post-intervention assessments, including validated questionnaires on eating behavior (DEBQ, FCQ, IES-2), body image (BAS, Stunkard Figure Rating Scale), and psychological well-being (WHO-5, Rosenberg Self-Esteem Scale), as well as a 3-day food diary. * Be randomly assigned to either the intervention group (8-week online non-diet nutrition education sessions) or the control group (no intervention). * Engage in 8 weekly, 60-minute sessions focused on intuitive eating, body acceptance, and health-promoting nutrition.

Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.

This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation. While micropigmentation is standard in nipple-areola complex (NAC) reconstruction, HA use remains novel, with limited data on psychosocial, sexual, and aesthetic outcomes. A sequential explanatory mixed-methods design will be used. In Phase 1, a randomized controlled trial will compare two groups: one receiving NAC micropigmentation alone (control) and the other receiving micropigmentation plus HA-based nipple projection (intervention). A total of 138 participants will be recruited at the Areolar Micropigmentation Unit of Germans Trias i Pujol University Hospital (Barcelona) over 36 months. Outcomes will include psychosocial and sexual well-being, satisfaction with breast and nipple appearance, and nipple projection, measured using the Spanish BREAST-Q, a custom satisfaction tool, and calipers. Phase 2 will involve a qualitative phenomenological study using semi-structured interviews with a purposive sample from the intervention group. Thematic analysis will explore body image, emotional and social well-being, and overall satisfaction, using NVivo software. This is the first study assessing HA nipple reconstruction by advanced practice nurses using validated patient-reported outcomes. While the BREAST-Q is appropriate, it may not fully capture emotional nuances, justifying qualitative exploration. HA durability is estimated at 6-9 months, but residual volume and satisfaction over time remain underexplored. HA's aesthetic footprint may allow reduced dosages in future applications. This minimally invasive technique may reduce the need for surgical nipple reconstruction. Conducting the procedure in a nurse-led setting is novel and may enhance patient-centered care and the role of nursing in post-mastectomy recovery. The study complies with the Declaration of Helsinki and Spanish biomedical regulations. Ethical approval was obtained. Participants will provide informed consent, and data will be anonymized and securely stored.

3-Dimensional Evaluation of Body Perception

The goal of this observational study is to evaluate the changing body perception of amputees aged 18-65 years using prostheses through different personal perspectives of the right-left distinction. In addition, we aimed to examine the relationship between possible changes in body perception and visual spatial perception and neurocognitive performances. The main questions that this study aimed to answer are as follows: 1. Is there a difference between the amputee group and the control group in terms of parameters related to body perception? 2. Is there a difference between the amputee group and the control group in terms of neurocognitive skills? 3. Is there any difference between the amputee group and the control group in terms of visual spatial perception abilities? To examine whether changes in body perception in amputees affect neurocognitive performance, visuospatial perception and perspective perception and the relationship between them will be compared with a healthy control group. The assessments to be applied to both groups can be summarised as follows: * Demographic information such as age, gender, and education level will be recorded. * Mini-mental state test will be used to assess the cognitive level. * Edinburgh Handedness Scale will be used to determine the dominant side. * Right-left discrimination and personal perspective perception will be assessed using a desktop programme. * The clock drawing test and Benton line orientation test will be used to visual spatial perception. * A computer based program called The Central Nervous System (CNS) Vital Signs Neurocognitive Test Battery will be used to asesses neurocognitive abilities.

Nature for Body Image

Nature exposure has been found to be particularly beneficial for body image, as recent studies have identified a positive association between time spent in nature and positive body image. Positive body image, defined as the ability to accept and respect one's body, has been linked to greater life satisfaction and engagement in healthy behaviors. Conversely, negative body image is recognized as a public health concern due to its detrimental effects on both physical and mental health. It has been associated with symptoms of Body Image Disorders (BIDs), including Eating Disorders (EDs) and Body Dysmorphic Disorder (BDD). The Nature for Body Image (NBI) project aimed to examine the impact of a structured nature exposure intervention on improving body image among young women aged 18-35 years.

A Single Session Community-Based Body Empowerment Session

This present study will examine the effectiveness of a single session, virtually delivered body empowerment program for decreasing participants thin ideal internalization. The intervention asks participants to identify cultural norms surrounding appearance and attractiveness, then challenge these ideals. Participants will answer questions about thin ideal internalization before and after the program.

More Than Body Appearance (MBA) Intervention

The promotion of a positive body image is crucial to increase the efficacy of psychological interventions targeting body image. Recent studies indicated that positive body image also acts as a protective factor against the onset of ED symptoms. However, in the last decades, research has predominantly focused on reducing body dissatisfaction, with most available psychological interventions for body image adopting a disease reduction perspective while neglecting positive aspects of psychological functioning. This approach has shown limited efficacy in improving body image. Consequently, it is crucial to develop new psychological interventions including both perspectives (i.e., disease reduction and health promotion perspectives) to improve body image and to test their efficacy in different contexts and populations. The aim of this study was to investigate the efficacy of a 2-week online psychological intervention (More than Body Appearance; MBA) designed to improve body image in young women at both high and low risk of developing Body Image Disorders and in female athletes practicing aesthetic sports.

Yoga 4 Body Image (Y4BI): Investigating the Impact of Yoga on Body Image and Eating Behaviours

The practice of yoga can positively impact body image, a psychological construct encompassing perceptual, emotional, cognitive, and behavioral aspects, which can be either positive or negative. Negative body image manifests as extreme dissatisfaction with one's body-a condition particularly common among young women-that places them at significant risk for developing Body Image Disorders (BIDs). In contrast, positive body image is characterized by an overall respect for one's body. Current research on the impact of yoga on body image has several limitations, making it challenging to determine whether yoga practice truly has a positive effect on body image and to identify the mechanisms underlying this impact. To address these gaps, the present project aims to overcome the limitations of existing studies by investigating the impact of yoga on body image through quantitative methodologies and by exploring the mechanisms that drive this effect. The project consists of two phases: 1. Investigating the impact of yoga on body image (both positive and negative) and eating behaviours in a population characterized by high levels of body dissatisfaction-young women. 2. Examining the psychological mechanisms underlying yoga's impact on body image, including increased interoceptive awareness, embodiment, and self-compassion, as well as a reduction in self-objectification.

The Weight of Victory: Exploring Short- and Long-term Health Outcomes in Former Male & Female Elite Athletes from Weight-sensitive Sports

The health of former elite athletes has been identified as a critical research gap where there is limited knowledge about both short- and long-term consequences after ending their careers. The transition phase from an active elite career to everyday life has been shown to be particularly problematic, yet this issue has been little studied among former Norwegian elite athletes. Furthermore, questions remain regarding the health of athletes from weight-sensitive sports, such as weight-class, aesthetic, and certain endurance sports. These athletes face specific challenges related to maintaining a certain physique and frequent changes in body weight during their active careers. This group has been shown to be vulnerable to a range of problematic health outcomes related to low energy availability, and little is known about the long-term effects of a career involving this. Therefore, the overall purpose of the project is to map the mental and physical health of former elite athletes. At the same time, there will be a particular focus on the differences between weight-sensitive and less weight-sensitive sports, different types of sports, gender, as well as previous dieting and eating behaviors.

Body Image and Physical Activity of Women with Breast Cancer

The goal of this self-initiated questionnaire-based follow-up clinical trial is to map the body image and physical activity of Hungarian women treated for breast cancer. The main questions it aims to answer are: 1. How body image changes during different treatments among women treated for breast cancer? 2. How is physical activity among Hungarian women treated for breast cancer?

Impact of Nipple Micropigmentation in Mastectomized Women

This will be a multicenter prospective descriptive case series study following a cohort. The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service. CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women.