Condition: 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 · Sponsor: University of Turin, Italy
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.
This description comes directly from the study's public registry record.
Antonella Granieri, Full Professor · 3204361389 · antonella.granieri@unito.it
Maria Domenica Sauta, PhD Student · 3402816558 · mariadomenica.sauta@unito.it
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| Head and Neck Cancer Unit, Asl Città di Torino | Turin, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07712120