Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Changes in post traumatic symptoms after the surgery — T0: Baseline T1: Before surgery T2: Follow-up visit within one month after surgery
  Changes in post traumatic symptoms * Total score. Range: 0-88. Higher scores mean a worse outcome. * Hyperarousal subscale. Range: 0-4. Higher scores mean a worse outcome. * Avoidance subscale. Range: 0-4. Higher scores mean a worse outcome. * Intrusion subscale. Range: 0-4. Higher scores mean a worse outcome

Trial sites (1)

More University of Turin, Italy trials in Italy

Other trials for the same condition