RecruitingNot applicableEN originalHead and neck cancer

Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the 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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Diagnoza raka głowy lub szyi, pacjent czeka na operację jamy ustnej lub gardła
  • Wiek co najmniej 18 lat
  • Umiejętność rozumienia i komunikacji w języku włoskim

✗ Disqualifies

  • Brak możliwości wyrażenia zgody na uczestnictwo w badaniu
  • Rozpoznane zaburzenia psychiatryczne
  • Rozpoznane problemy z pamięcią lub myśleniem
  • Aktualnie odbierana terapia psychologiczna lub psychoterapia

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 17, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Head and Neck Cancer Unit, Asl Città di Torino

Turin, Italy

Trial contact

Antonella Granieri, Full Professor

Maria Domenica Sauta, PhD Student

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/18/2026.

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