Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer

Recruiting now · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07712120

Run by

University of Turin, Italy

People needed

58

Starts

2025-11-20

Expected to finish

2027-11-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the following criteria:
• Patients with a diagnosis of head and neck cancer scheduled to undergo demolitive surgery of the oral cavity or oropharynx, with or without simultaneous flap reconstruction.
• Age ≥18 years at the time of signing the informed consent form.
• Ability to understand and communicate in Italian.

You may not qualify if…

• Participants will be excluded if they:
• Are unable to provide written informed consent.
• Have a diagnosed psychiatric disorder.
• Have a diagnosed neurocognitive impairment.
• Are currently undergoing psychological or psychotherapeutic treatment.

Where it is running

• Head and Neck Cancer Unit, Asl Città di Torino — Turin, Italy (enrolling)

Full record on ClinicalTrials.gov

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