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Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer

NCT07712120 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-07-17

No results posted yet for this study

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.

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

Interventions

OTHER

Brief 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.

Sponsors & Collaborators

  • ASL Città di Torino, Italy

    collaborator UNKNOWN

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Monica Agnesone, Director, Psychology Unit · ASL Città di Torino

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2026-02-23
Completion
2027-11-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712120 on ClinicalTrials.gov