Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Planned participants: 58
• From Nov 2025 to the primary completion date, Feb 2026
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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