the aim of this study was to compare the effects of Benson and progressive muscle relaxation on the severity of pain after laminectomy surgery
Design
93 patients were randomly divided into three intervention groups including Benson relaxation, progressive muscle relaxation and control. Random assignment was performed by use of dice numbers. Patients in all groups received routine treatment (analgesic medications) in addition to corresponding interventions.
Settings and conduct
This study was performed on patients undergoing lumbar laminectomy in selected AJA hospital in Tehran. Relaxation techniques were done at three stages after laminectomy (2, 12 and 24 hours after recovery). Severity of pain was assesse before and 20 minutes after each relaxation period using visual analogue scale (VAS).
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range of 18-65 years, ability of learning, being interested to do relaxation techniques and having permission from own physician.
Exclusion criteria: psychological disorders, cognitive impairments, addiction to opioids, those who used sleeping pills and muscle relaxant drugs.
Intervention groups
Intervention group 1 (Benson relaxation): Patients in this group performed Benson relaxation technique.This procedure including lie down, closing the eyes, relaxing the muscles from the bottom up, starting to breathe slowly, continuing to breathe slowly as the muscles relax, open Eyes slowly and away from negative thoughts.
Intervention group 2 (progressive muscle relaxation): Patients in this group performed progressive muscle relaxation technique. In this method, the individual relaxes each of his muscles (from the leg muscles to the facial muscles) by counting to 5 contractions and then counting to 10.
group 3 (control group): In this group no relaxation techniques were performed on the patients.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161213031385N3
Registration date:2020-01-10, 1398/10/20
Registration timing:retrospective
Last update:2020-01-10, 1398/10/20
Update count:0
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Seyed Amir Hosein Pishgooie
Name of organization / entity
Army university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 7750 0201
Email address
ah.pishgooie@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-23, 1395/07/02
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
2016-09-23, 1395/07/02
Actual recruitment end date
2016-12-20, 1395/09/30
Trial completion date
2016-12-21, 1395/10/01
Scientific title
Comparative study on the effect of benson and progressive muscle relaxation techniques on the severity of pain after laminectomy
Public title
The effect of relaxation techniques on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ability of learning
having reading and writing skills
being interested to do relaxation techniques
having permission from own physician
Exclusion criteria:
psychological disorders
hearing and motor disorders
addiction to opioids
those who used sleeping pills and muscle relaxant drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
93
Actual sample size reached:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected by a consecutive sampling method and randomly assigned to three groups of Benson relaxation (n=31), progressive muscle relaxation (n=31), and control (n=31).
Dice were used to randomly assign individuals to groups.Dice number 1 and 2 were assigned for Benson relaxation group, 3 and 4 for progressive muscle relaxation and 5 and 6 for control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of aja university of medical sciences
Street address
aja university of medical sciences, Etemadzade st, Fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2016-08-21, 1395/05/31
Ethics committee reference number
IR.AJAUMS.REC.1395.13
Health conditions studied
1
Description of health condition studied
Pain after Laminectomy
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Patients' pain score based on VAS scale
Timepoint
Before surgery, 2, 12 and 24 hours after consciousness
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Benson relaxation group _ In this group, patients performed the Benson relaxation technique, which is a passive relaxation technique. This relaxation procedure is done in six steps, including lie down, closing the eyes, relaxing the muscles from the bottom up (without active contraction), starting to breathe slowly, continuing to breathe slowly as the muscles relax, open Eyes slowly and away from negative thoughts. This technique was performed three times after laminectomy (2, 12 and 24 hours after consciousness). Pain intensity was measured before and 20 minutes after each relaxation by visual analogue scale (VAS).
Category
Behavior
2
Description
Intervention group 2: Progressive muscle relaxation group _ Patients in this group performed progressive muscle relaxation techniques, which are active relaxation techniques.In this method, the individual relaxes each of his muscles (from the leg muscles to the facial muscles) by counting to 5 contractions and then counting to 10.These steps are respectively for the leg muscles, femurs, abdomen, chest, buttocks, hands and forearm, arms, shoulders, neck, forehead, tongue and jaw, eyes and face until the patient feels his whole body loosely integrated, Has been repeated. This technique was performed three times after laminectomy (2, 12 and 24 hours after consciousness). Pain intensity was measured before and 20 minutes after each relaxation by visual analogue scale (VAS).
Category
Behavior
3
Description
Control group: Individuals in the control group received only routine treatment and they were not given any training or relaxation technique
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Reza Momen
Street address
Emam Reza Hospital, Etemadzade st, Fatemi st, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۸۵۴۱
Phone
+98 21 8609 6350
Email
bimaemamreza@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Armin Zareian
Street address
AJA University of Medical Sciences, Etemadzade st, Fatemi st, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
a.zareian@ajamus.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Momen
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Etemadzade st, Fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
rezamomen88@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Momen
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Etemadzade st, fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
rezamomen88@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Momen
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Etemadzade St, Fatemi St
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 5565 6832
Email
rezamomen88@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Pain score and demographic information
When the data will become available and for how long
3 months after the completion of the study
To whom data/document is available
Researchers in Medical Sciences
Under which criteria data/document could be used
unlimited
From where data/document is obtainable
Send email to rezamomen88@yahoo.com
What processes are involved for a request to access data/document