Clinical trial · Interventional
Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer
Integrating Clinical Psychology Into the Care of Patients With Head and Neck Cancer: A Pilot Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Demolitive Surgical Procedures on the Oral Cavity or Oropharynx, With or Without Simultaneous Reconstruction Using Flaps | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Surgery for Head and Neck Cancer Patients | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brief clinical psychological intervention using biofeedback techniques | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Assignment to the experimental and control groups will be performed using block randomization with variable block lengths. The stratification criteria are as follows: * Gender: Male (M) vs. Female (F) * Type of intervention: with vs. without simultaneous reconstruction with flaps. The intervention consists of two clinical-psychological interviews with a psychoanalytic framework, each lasting 60 minutes, integrating biofeedback techniques. Interviews will be recorded and transcribed verbatim.
- interventionNames
- Other: Brief clinical psychological intervention using biofeedback techniques
- type
- NO_INTERVENTION
- label
- Control Group
Primary outcomes (1)
- measure
- Changes in post traumatic symptoms after the surgery
- timeFrame
- T0: Baseline T1: Before surgery T2: Follow-up visit within one month after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 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 Criteria Participants will be excluded if they: * Are unable to provide written informed consent. * Have a diagnosed psychiatric disorder. * Have a diagnosed neurocognitive impairment. * Are currently undergoing psychological or psychotherapeutic treatment.
References
Publications (28)
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- BACKGROUNDKrueger RF, Derringer J, Markon KE, Watson D, Skodol AE. Initial construction of a maladaptive personality trait model and inventory for DSM-5. Psychol Med. 2012 Sep;42(9):1879-90. doi: 10.1017/S0033291711002674. Epub 2011 Dec 8. PMID 22153017
- BACKGROUNDRaimondi G, Samela T, Lester D, Imperatori C, Carlucci L, Contardi A, Balsamo M, Innamorati M. Psychometric Properties of the Italian Mentalization Questionnaire: Assessing Structural Invariance and Construct Validity. J Pers Assess. 2022 Sep-Oct;104(5):628-636. doi: 10.1080/00223891.2021.1991362. Epub 2021 Oct 25. PMID 34694942
- BACKGROUNDHausberg MC, Schulz H, Piegler T, Happach CG, Klopper M, Brutt AL, Sammet I, Andreas S. Is a self-rated instrument appropriate to assess mentalization in patients with mental disorders? Development and first validation of the mentalization questionnaire (MZQ). Psychother Res. 2012;22(6):699-709. doi: 10.1080/10503307.2012.709325. Epub 2012 Aug 6. PMID 22867004
- BACKGROUNDPalmieri G, Evans C, Hansen V, Brancaleoni G, Ferrari S, Porcelli P, Reitano F, Rigatelli M. Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM). Clin Psychol Psychother. 2009 Sep-Oct;16(5):444-9. doi: 10.1002/cpp.646. PMID 19701881
- BACKGROUNDEvans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, Audin K. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002 Jan;180:51-60. doi: 10.1192/bjp.180.1.51. PMID 11772852