Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04845334
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2021-02-03
Brief Title:
Complementary and Alternative Medicine Interventions in Targeting Pain
Sponsor:
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
Organization:
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
Study Overview
Official Title:
Complementary and Alternative Medicine Interventions in Targeting Pain
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP
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
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 patientsyears expected quadrantectomies 80 patientsyears expected
Neurosurgery patient scheduled for spinal fusion with non-traumatic etiology 225 patientsyears expected
Vascular Surgery patient scheduled for carotid stenosis or abdominal aortic aneurysm 205 patientsyears expected
With an expected population of 570 surgical patients in the recruitment period an a priori power analysis conducted with GPower Faul et al 2007 indicated that a total sample size of 82 participants was required α 005 1-β 080 d 025
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 subjects group assignment In addition for blinded purposes the study participants were instructed not to discuss the intervention with anyone
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 patientsyears expected quadrantectomies 80 patientsyears expected
Neurosurgery patient scheduled for spinal fusion with non-traumatic etiology 225 patientsyears expected
Vascular Surgery patient scheduled for carotid stenosis or abdominal aortic aneurysm 205 patientsyears expected
With an expected population of 570 surgical patients in the recruitment period an a priori power analysis conducted with GPower Faul et al 2007 indicated that a total sample size of 82 participants was required α 005 1-β 080 d 025
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 subjects group assignment In addition for blinded purposes the study participants were instructed not to discuss the intervention with anyone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None