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Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer
Sponsor: University of Turin, Italy
Summary
Head and neck cancer and its surgical treatment may significantly affect patients' psychological well-being, body image, somatic experience, and quality of life. This pilot randomized controlled non-pharmacological study aims to evaluate the short-term efficacy of a brief clinical psychological intervention including biofeedback techniques in reducing post-traumatic stress symptoms in patients undergoing demolitive surgery of the oral cavity or oropharynx, with or without simultaneous flap reconstruction. Secondary objectives are to evaluate the effects of the intervention on somatopsychic distress and quality of life, assess the persistence of intervention effects over time, and examine the impact of flap reconstruction on patients' psychological outcomes and quality of life. Eligible participants will be randomly assigned to either an experimental group receiving two 60-minute clinical psychological sessions integrating biofeedback techniques or a control group receiving standard care without the study intervention. Psychological and clinical assessments will be performed at baseline (before surgery), at hospital admission for surgery, and at the post-discharge follow-up visit.
Official title: Integrating Clinical Psychology Into the Care of Patients With Head and Neck Cancer: A Pilot Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2025-11-20
Completion Date
2027-11
Last Updated
2026-07-17
Healthy Volunteers
No
Conditions
Interventions
Brief clinical psychological intervention using biofeedback techniques
Intervention type: Clinical psychological intervention using biofeedback tecniques. The intervention consists of two 60-minute clinical psychological sessions with a psychoanalytic framework. A biofeedback device with physiological sensors is used during the sessions to monitor physiological responses and provide real-time feedback during patients' diaphragmatic breathing. The biofeedback device does not constitute a separate intervention. During the first session, the clinician explores the patient's illness history, emotions, relationships, and experience of diagnosis and surgery. A biofeedback baseline is recorded, followed by diaphragmatic breathing training to support emotional regulation. In the second session, the clinician discusses the patient's experience after training, changes in emotions, and expectations about surgery and recovery. Biofeedback and breathing exercises are repeated.
Locations (1)
Head and Neck Cancer Unit, Asl Città di Torino
Turin, Italy