Complementary and Alternative Medicine Interventions in Targeting Pain

NCT04845334 | Completed

• 1 other identifier: ASO.Psg.15.01
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Controlled Randomized Clinical Trial aimed at determining the effectiveness of a modified RR intervention in reducing post-operative pain and psychological symptoms in patients undergoing surgery intervention. Researches hypothesized that compared to controls patients undergoing modified RR intervention were characterized by

1. 1.improved capability to discriminate emotions from bodily feelings;
2. 2.reduce emotional distress;
3. 3.reduced pain perception.

Conditions

Quadrantectomies; Spinal Fusion; Carotid Stenosis; Abdominal Aortic Aneurysm; Colectomy

Keywords

Relaxation response; Surgiva stress; Pain; Distress; Emotion regulation

Outcome Measures

Primary Outcomes (5)

• Changes in alexithymia (TAS scores) following a specific short psycho-corporeal intervention

  Changes in the Toronto Alexithymia Scale (TAS-20) scores following a specific short psychocorporeal intervention * Total score. Range: 20-100. Higher scores mean a worse outcome. * Difficulty in Identifying Feelings (TAS-DIF). Range: 7-35. Higher scores mean a worse outcome. * Difficulty in Describing Feelings (TAS-DDF). Range: 5-25. Higher scores mean a worse outcome. * Externally Oriented Thinking (TAS-EOT). Range: 8-40. Higher scores mean a worse outcome.

  Baseline; The morning before the surgical intervention; At discharge, assessed up to 10 days; 3 months after the surgical intervention

• Changes in anxiety and depression (HADS scores) following a specific short psycho-corporeal intervention

  Changes in the Hospital Anxiety and Depression Scale (HADS) scores following a specific short psycho-corporeal intervention. * Anxiety score. Range: 0-21. Higher scores mean a worse outcome. * Depression score. Range: 0-21. Higher scores mean a worse outcome.

  [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]

• Changes in post-traumatic distress (IES-R scores) following a specific short psycho-corporeal intervention

  Changes in the Impact of Event Scale - Revised (IES-R) scores following a specific short psycho-corporeal intervention * 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.

  [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]

• Changes in pain intensity perception (NRS scores) following a specific short psycho-corporeal intervention

  Changes in the Numeric Rating Scale (NRS) scores following a specific short psycho-corporeal intervention • Total score. Range: 0-10. Higher scores mean a worse outcome.

  [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]

• Changes in psychological distress (ET scores) following a specific short psycho-corporeal intervention

  Changes in the Emotion Thermometer (ET) scores following a specific short psycho-corporeal intervention * Distress scale. Range: 0-10. Higher scores mean a worse outcome. * Anxiety scale. Range: 0-10. Higher scores mean a worse outcome. * Depression scale. Range: 0-10. Higher scores mean a worse outcome. * Anger scale. Range: 0-10. Higher scores mean a worse outcome. * Need for help scale. Range: 0-10. Higher scores mean a worse outcome.

  [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]

Secondary Outcomes (1)

• Effectiveness of the short psycho-corporeal intervention in reducing the use of analgesic drugs.

  [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]

Study Arms (2)

Clinical RR intervention

EXPERIMENTAL

Clinical RR intervention

Behavioral: RR intervention

Standard care

NO INTERVENTION

Standard care

Interventions

RR intervention BEHAVIORAL

The short psychological intervention consists of a narrative interview and a psychocorporeal intervention. Narrative interview: this is an interview aimed at exploring the experience and awareness of illness. The sharing of the dimension of pain and suffering, the verbalization of emotions, the narration of the history of illness, expectations and fears related to the intervention will be aimed at an emotional and cognitive restructuring of the experience of illness, improving the perception of internal resources and resilience. Psycho-corporeal intervention:it is a training to the psychophysiological technique of the "Relaxation Response" (R.R.) of Hebert Benson (Mind-Body Medical Institute of Havard), aimed at stress management and consequently at reducing the perception of pain

Clinical RR intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients waiting for a surgical intervention in the Departments of Vascular Surgery, General Surgery and Neurosurgery;
• age ≥ 18 years.

You may not qualify if:

• having a poor knowledge of the Italian language;
• having a cognitive impairment;
• having a certified psychiatric diagnosis;
• having a certified diagnosis of a neurodegenerative disease (i.e., Alzheimer disease, Parkinson disease, etc.)
• having been in psychiatric or psychological therapy in the last 6 months

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead
• Scuola di Specializzazione in Psicologia Clinica dell'Università degli Studi di Torino: collaborator
• Fondazione CRT: collaborator

Related Publications (23)

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  PMID: 4810622 BACKGROUND

• Casey A, Chang BH, Huddleston J, Virani N, Benson H, Dusek JA. A model for integrating a mind/body approach to cardiac rehabilitation: outcomes and correlators. J Cardiopulm Rehabil Prev. 2009 Jul-Aug;29(4):230-8; quiz 239-40. doi: 10.1097/HCR.0b013e3181a33352.

  PMID: 19451830 BACKGROUND

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• Chang BH, Casey A, Dusek JA, Benson H. Relaxation response and spirituality: Pathways to improve psychological outcomes in cardiac rehabilitation. J Psychosom Res. 2010 Aug;69(2):93-100. doi: 10.1016/j.jpsychores.2010.01.007. Epub 2010 Mar 1.

  PMID: 20624507 BACKGROUND

• Glaros AG, Lumley MA. Alexithymia and pain in temporomandibular disorder. J Psychosom Res. 2005 Aug;59(2):85-8. doi: 10.1016/j.jpsychores.2005.05.007.

  PMID: 16186003 BACKGROUND

• Honkalampi K, Hintikka J, Laukkanen E, Lehtonen J, Viinamaki H. Alexithymia and depression: a prospective study of patients with major depressive disorder. Psychosomatics. 2001 May-Jun;42(3):229-34. doi: 10.1176/appi.psy.42.3.229.

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• Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.

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• Villemure C, Bushnell CM. Cognitive modulation of pain: how do attention and emotion influence pain processing? Pain. 2002 Feb;95(3):195-199. doi: 10.1016/S0304-3959(02)00007-6. No abstract available.

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• Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1.

  PMID: 8126686 BACKGROUND

• Bagby RM, Taylor GJ, Parker JD. The Twenty-item Toronto Alexithymia Scale--II. Convergent, discriminant, and concurrent validity. J Psychosom Res. 1994 Jan;38(1):33-40. doi: 10.1016/0022-3999(94)90006-x.

  PMID: 8126688 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Olsson I, Mykletun A, Dahl AA. The Hospital Anxiety and Depression Rating Scale: a cross-sectional study of psychometrics and case finding abilities in general practice. BMC Psychiatry. 2005 Dec 14;5:46. doi: 10.1186/1471-244X-5-46.

  PMID: 16351733 BACKGROUND

• Craparo G, Faraci P, Rotondo G, Gori A. The Impact of Event Scale - Revised: psychometric properties of the Italian version in a sample of flood victims. Neuropsychiatr Dis Treat. 2013;9:1427-32. doi: 10.2147/NDT.S51793. Epub 2013 Sep 19.

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• McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.

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• Jensen MP, Moore MR, Bockow TB, Ehde DM, Engel JM. Psychosocial factors and adjustment to chronic pain in persons with physical disabilities: a systematic review. Arch Phys Med Rehabil. 2011 Jan;92(1):146-60. doi: 10.1016/j.apmr.2010.09.021.

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• Jensen MP, McFarland CA. Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain. 1993 Nov;55(2):195-203. doi: 10.1016/0304-3959(93)90148-I.

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• Johnson C. Measuring Pain. Visual Analog Scale Versus Numeric Pain Scale: What is the Difference? J Chiropr Med. 2005 Winter;4(1):43-4. doi: 10.1016/S0899-3467(07)60112-8.

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• Mitchell AJ, Morgan JP, Petersen D, Fabbri S, Fayard C, Stoletniy L, Chiong J. Validation of simple visual-analogue thermometer screen for mood complications of cardiovascular disease: the Emotion Thermometers. J Affect Disord. 2012 Feb;136(3):1257-63. doi: 10.1016/j.jad.2011.06.008. Epub 2011 Jul 1.

  PMID: 21723618 BACKGROUND

• Schubart JR, Mitchell AJ, Dietrich L, Gusani NJ. Accuracy of the Emotion Thermometers (ET) screening tool in patients undergoing surgery for upper gastrointestinal malignancies. J Psychosoc Oncol. 2015;33(1):1-14. doi: 10.1080/07347332.2014.977415.

  PMID: 25396697 BACKGROUND

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  PMID: 17695343 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis; Aortic Aneurysm, Abdominal; Pain; Emotional Regulation

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aneurysm; Aortic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Study Officials

• Antonella Granieri, Professor

  Dipartimento di Psicologia dell'Università degli Studi di Torino

  STUDY DIRECTOR

• Fanny Guglielmucci, PhD

  Dipartimento di Psicologia dell'Università degli Studi di Torino

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: April 14, 2021
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share