Clinical trial NCT04845334: Complementary and Alternative Medicine Interventions in Targeting Pain
Official title: Complementary and Alternative Medicine Interventions in Targeting Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quadrantectomies
Spinal Fusion
Carotid Stenosis
Abdominal Aortic Aneurysm
Colectomy
Keywords: Relaxation response
Surgiva stress
Pain
Distress
Emotion regulation
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
Collaborators: name: Scuola di Specializzazione in Psicologia Clinica dell'Università degli Studi di Torino
name: Fondazione CRT
First posted: 2021-04-14
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in alexithymia (TAS scores) following a specific short psycho-corporeal intervention
timeFrame: Baseline; The morning before the surgical intervention; At discharge, assessed up to 10 days; 3 months after the surgical intervention
measure: Changes in anxiety and depression (HADS scores) following a specific short psycho-corporeal intervention
timeFrame: [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]
measure: Changes in post-traumatic distress (IES-R scores) following a specific short psycho-corporeal intervention
timeFrame: [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]
measure: Changes in pain intensity perception (NRS scores) following a specific short psycho-corporeal intervention
timeFrame: [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]
measure: Changes in psychological distress (ET scores) following a specific short psycho-corporeal intervention
timeFrame: [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:
measure: Effectiveness of the short psycho-corporeal intervention in reducing the use of analgesic drugs.
timeFrame: [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]
Other outcomes:
Locations:
Study officials:
affiliation: Dipartimento di Psicologia dell'Università degli Studi di Torino
name: Antonella Granieri, Professor
role: STUDY_DIRECTOR
affiliation: Dipartimento di Psicologia dell'Università degli Studi di Torino
name: Fanny Guglielmucci, PhD
role: STUDY_DIRECTOR
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