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Brief Psychological Support With Biofeedback for Head and Neck Cancer Surgery Patients

Tests brief psychological sessions with biofeedback in adults having surgery for head and neck cancer.

Plain-language title generated from the registry record
Registry title: Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer

Key facts

Where
Turin, ItalySee the site

Where in Italy

  • Head and Neck Cancer Unit, Asl Città di TorinoTurin, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Turin, Italy
Trial code
NCT07712120
Record updated
17 July 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

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

ClinicalTrials.gov NCT07712120