Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04845334
Other study ID # ASO.Psg.15.01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date June 2017

Study information

Verified date July 2021
Source Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. improved capability to discriminate emotions from bodily feelings; 2. reduce emotional distress; 3. reduced pain perception. Moreover, researches hypothesized that (4) these effects were maintained over time.


Description:

A Controlled Randomized Clinical Trial of a RR intervention for surgical patients was conducted in the SS. Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy. Fifty-six patients were treated with the clinical RR intervention, while 62 patients were recruited as controls. Variables were assessed through an ad hoc questionnaire and a pool of self-report questionnaires validated for the Italian population: the Toronto Alexithymia Scale (TAS-20), the Hospital Anxiety and Depression Scale (HADS), the Impact of Event Scale - Revised (IES-R), the Numeric Rating Scale (NRS), and the Emotion Thermometer (ET). The TAS-20 is a frequently used 20-items self-report measure of alexithymia. A score ≥ 61 is considered to be indicative of alexithymia, whereas scores between 51 and 60 indicate borderline alexithymia. It has a 3-factor structure: Difficulty in Identifying Feelings (TAS-DIF); Difficulty in Describing Feelings (TAS-DDF), and Externally Oriented Thinking (TAS-EOT). The HADS is a brief, reliable self-report measure used to assess anxiety and depression in hospitalized and ambulatory medical patients, as well as in primary care and research. It consists of 7 items for anxiety (HADS-A) and 7 for depression (HADS-D). Scores > 8 in each subscale are indicative of clinically relevant anxiety and depression, respectively. The IES-R is a widely used 22-items self-report measure of subjective distress caused by traumatic events. It considers three independent dimensions: intrusion, avoidance, and hyper-arousal. The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numeric version of the visual analog scale (VAS), in which respondents select the number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line. The ET is a simple, self-report measure of four emotion domains (distress, anxiety, depression, and anger) and one non-emotion domain (need for help). Respondents have to rate each dimension on a vertical visual analogue scale (thermometer), with the anchors 0 and 10, to indicate which level of distress they experienced over the previous week. Outcome measures were administered at 4 time-points: T0: Baseline (3 months before the surgical intervention). - Baseline alexithymia levels assessed with the TAS-20; - baseline anxiety and depression levels assessed with the HADS; - baseline post-traumatic distress assessed with the IES-R; - baseline pain intensity assessed with the NRS; - baseline psychological distress assessed with the ET; - baseline use of analgesic drugs assessed with an ad hoc question. T1: The morning before the surgical intervention. - Changes in alexithymia levels assessed with the TAS-20; - changes in anxiety and depression levels assessed with the HADS; - changes in post-traumatic distress assessed with the IES-R; - changes in pain intensity assessed with the NRS; - changes in psychological distress assessed with the ET; - changes in use of analgesic drugs assessed with an ad hoc question. T2: At discharge, assessed up to 10 days. - Changes in alexithymia levels assessed with the TAS-20; - changes in anxiety and depression levels assessed with the HADS; - changes in post-traumatic distress assessed with the IES-R; - changes in pain intensity assessed with the NRS; - changes in psychological distress assessed with the ET; - changes in use of analgesic drugs assessed with an ad hoc question. T3: 3 months after the surgical intervention. - Changes in alexithymia levels assessed with the TAS-20; - changes in anxiety and depression levels assessed with the HADS; - changes in post-traumatic distress assessed with the IES-R; - changes in pain intensity assessed with the NRS; - changes in psychological distress assessed with the ET; - changes in use of analgesic drugs assessed with an ad hoc question. Subjects in the RR group underwent the clinical interventions between T0 and T1, while the controls underwent standard care. Ethics The study was reviewed and approved by the Institutional Review Board (IRB) of the SS. Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy. All participants gave informed written consent before entering the study. All research procedures were conducted in accordance with the ethical standards of the committees responsible for human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Participants Patients were recruited between January 2015 and June 2017. Patients in the Departments of Vascular Surgery, General Surgery and Neurosurgery were included, considering their similarities for what concerns surgical impact, recovery, and post-recovery expectation. Expected surgical patients in the recruitment period were computed considering the prevalent frequency of each specific intervention in every Department: - General Surgery: patients scheduled for right hemicolectomies (60 patients/years expected), quadrantectomies (80 patients/years expected); - Neurosurgery: patient scheduled for spinal fusion with non-traumatic etiology (225 patients/years expected) - Vascular Surgery: patient scheduled for carotid stenosis or abdominal aortic aneurysm (205 patients/years expected). With an expected population of 570 surgical patients in the recruitment period, an a priori power analysis conducted with G*Power (Faul et al., 2007) indicated that a total sample size of 82 participants was required (α = 0.05; 1-β = 0.80; d = 0.25). Randomization and blinding: A block randomization method was used with block size of 4, stratified by age, gender and clinical conditions. A series of numbers was generated in advance using a computer program. Following completion of the baseline measures, a research assistant assigned a study group to each participant, following the series generated by the computers. This research assistant as well as the personnel involved in the RR inspired intervention were aware of the patient-group assignment. Remaining study personnel were blind to subject's group assignment. In addition, for blinded purposes, the study participants were instructed not to discuss the intervention with anyone.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients waiting for a surgical intervention in the Departments of Vascular Surgery, General Surgery and Neurosurgery; - age = 18 years. Exclusion Criteria: - 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

Study Design


Intervention

Behavioral:
RR intervention
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

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria Fondazione CRT, Scuola di Specializzazione in Psicologia Clinica dell'Università degli Studi di Torino

References & Publications (23)

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. — View Citation

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. — View Citation

Benson H, Beary JF, Carol MP. The relaxation response. Psychiatry. 1974 Feb;37(1):37-46. — View Citation

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. — View Citation

Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Preoperative predictors of moderate to intense acute postoperative pain in patients undergoing abdominal surgery. Acta Anaesthesiol Scand. 2002 Nov;46(10):1265-71. — View Citation

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. — View Citation

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. — View Citation

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. — View Citation

Glaros AG, Lumley MA. Alexithymia and pain in temporomandibular disorder. J Psychosom Res. 2005 Aug;59(2):85-8. — View Citation

Honkalampi K, Hintikka J, Laukkanen E, Lehtonen J, Viinamäki H. Alexithymia and depression: a prospective study of patients with major depressive disorder. Psychosomatics. 2001 May-Jun;42(3):229-34. — View Citation

Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Lumley JW, Fielding GA, Rhodes M, Nathanson LK, Siu S, Stitz RW. Laparoscopic-assisted colorectal surgery. Lessons learned from 240 consecutive patients. Dis Colon Rectum. 1996 Feb;39(2):155-9. — View Citation

McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. Review. — View Citation

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. — View Citation

Olssøn 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. — View Citation

Rodriguez CS. Pain measurement in the elderly: a review. Pain Manag Nurs. 2001 Jun;2(2):38-46. Review. — View Citation

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. — View Citation

Tuzer V, Bulut SD, Bastug B, Kayalar G, Göka E, Bestepe E. Causal attributions and alexithymia in female patients with fibromyalgia or chronic low back pain. Nord J Psychiatry. 2011 Apr;65(2):138-44. doi: 10.3109/08039488.2010.522596. Epub 2010 Sep 27. — View Citation

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. Review. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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]
Primary 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]
Primary 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]
Primary 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 Effectiveness of the short psycho-corporeal intervention in reducing the use of analgesic drugs. 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]
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04227054 - Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks N/A
Active, not recruiting NCT03687489 - Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System N/A
Active, not recruiting NCT03507413 - Metformin Therapy in Non-diabetic AAA Patients Phase 2/Phase 3
Not yet recruiting NCT05756283 - The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair N/A
Not yet recruiting NCT04089241 - Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair N/A
Active, not recruiting NCT02604303 - A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
Completed NCT02229006 - Sodium Fluoride Imaging of Abdominal Aortic Aneurysms N/A
Completed NCT02224794 - LIFE Study: Least Invasive Fast-Track EVAR
Terminated NCT02469376 - Evaluation of a New Imagingtechnologie for Thrombosis Phase 1
Terminated NCT01843335 - Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair N/A
Completed NCT01118520 - AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) Phase 2
Terminated NCT01425242 - Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension N/A
Completed NCT00746122 - Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair N/A
Completed NCT03952780 - Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Completed NCT00583414 - Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients N/A
Recruiting NCT05864560 - Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Completed NCT01683084 - Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms Phase 4
Active, not recruiting NCT03180996 - Global Fenestrated Anaconda Clinical sTudy
Completed NCT02493296 - The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
Completed NCT03320408 - Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers