RecruitingNot ApplicableNCT07712120

Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer

Integrating Clinical Psychology Into the Care of Patients With Head and Neck Cancer: A Pilot Randomized Controlled Trial

Sponsor

University of Turin, Italy

Enrollment

58 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer Surgery for Head and Neck Cancer Patients Demolitive Surgical Procedures on the Oral Cavity or Oropharynx, With or Without Simultaneous Reconstruction Using Flaps

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Brief clinical psychological intervention using biofeedback techniques for people with demolitive surgical procedures on the oral cavity or oropharynx, with or without simultaneous reconstruction using flaps, head and neck cancer, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBrief 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.