A comparative study of the effect of Benson relaxation and music therapy on fear of movement and postoperative pain in patients undergoing lumbar disc herniation surgery
General purpose: Determining and comparing the effect of Benson relaxation and music therapy on fear of movement and postoperative pain in patients undergoing lumbar disc herniation surgery.
Design
Clinical trial with two intervention groups and one control group, parallel, single-blind, randomized, on 90 patients.
Settings and conduct
This single-score study will be conducted in Imam Hossein (AS) Shahrood Hospital. The researcher, being present at the patient's bedside on the day after the operation, after checking the entry criteria, randomly assigns the patients. Then according to the group in which the patient is placed (Benson's relaxation group, music therapy and control group), the relevant intervention will be done. For the control group, only routine care will be done. Then the pain and fear of moving the patients in 3 stages It will be measured by the standard instrument designed.
Participants/Inclusion and exclusion criteria
Entry criteria include:
1. Perform discectomy
2. Being 18 years old or older
3. Having spontaneous breathing
4. Ability to read and write in Persian language
5. Ability to learn or perform the Benson technique correctly
6. Desire to listen to music
Intervention groups
Benson's relaxation: The technique of this method will be taught to the patient.
Music therapy: listening to music without words for 20 minutes
Control: will receive only routine care.
Main outcome variables
Fear of movement, postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230911059401N1
Registration date:2023-10-11, 1402/07/19
Registration timing:registered_while_recruiting
Last update:2023-10-11, 1402/07/19
Update count:0
Registration date
2023-10-11, 1402/07/19
Registrant information
Name
majid bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3251 2173
Email address
majidbagheri.96913@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-04-29, 1403/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of Benson relaxation and music therapy on fear of movement and postoperative pain in patients undergoing lumbar disc herniation surgery
Public title
A comparative study of the effect of Benson relaxation and music therapy on fear of movement and postoperative pain in patients undergoing lumbar disc herniation surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Perform discectomy surgery
Being 18 years of age or older
Having spontaneous breathing
Ability to read and write in Persian
Ability to learn or perform the Benson technique correctly
Desire to listen to music
Consent to participate in the research verbally and in writing
Discectomy by open surgery
Having a score of at least 37 in the Tempa questionnaire before the operation
Having a pain score of at least 3 before surgery
Exclusion criteria:
Addiction to sedatives
lack of consciousness
causing any side effects in terms of infection, bleeding, severe pain, etc. until the end of evaluation and interventions
Having language, hearing or vision disorders
Having experience using relaxation methods in the past
Having a history of previous discectomy surgery
Having a history of taking sedatives, painkillers for a period of more than one month according to the patient's self-report
Having a history of mental disorders and diseases
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate the samples, the block randomization method will be used with the size of 6 blocks, so that by using the random number generation software in the block method, the randomization sequence will be produced according to the required sample size for the three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is single blind.
Due to the nature of the study, it is not possible to blind the study participants. However, measures have been taken in collecting information. The person collecting information will not be aware of the type of group of people after the intervention. . Also, in the statistical file and questionnaires, the groups are identified as codes, and the analyst does not know about the assignment of codes to the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
36147-73943
Approval date
2023-09-11, 1402/06/20
Ethics committee reference number
IR.SHMU.REC.1402.088
Health conditions studied
1
Description of health condition studied
Fear of movement, Low back pain, lumbar disc herniation
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
fear of movement
Timepoint
Once in the morning after the operation, and once in the morning two days after the operation
Method of measurement
Tampa Scale for Kinesiophobia
2
Description
postoperative pain
Timepoint
Once in the morning after the operation, and once in the morning two days after the operation
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (Benson Relaxation Group): In order to perform the correct Benson relaxation technique, this technique will be performed with the following sequence. The patient is asked to lie down in a comfortable position and close his eyes, to remove disturbing thoughts from his mind as much as possible. They are asked to choose a word that always reminds them of peace. Then slowly relax your muscles from the bottom of the body to the top and at the same time slowly start breathing deeply (in such a way that inhale through the nose and exhale through the mouth). Do not think and continue this exercise for at least 20 minutes. Finally, the patient is asked to open his eyes slowly, so that the body is motionless for a few minutes. The first day after the operation, when the pain and fear of movement are the most intense, therefore, the interventions are performed in two times with an interval of twelve hours at 9 am and 9 pm in the surgical department for 20 minutes.
Category
Rehabilitation
2
Description
Intervention group 2 (Music therapy group): Second group (music therapy group): Participants in the other group listen to wordless music for 20 minutes through an audio player. In the music therapy group, the song Weightless by Macaroni Union will be chosen as the wordless music. The melodies of this song have no repetitive pattern and its rhythm varies continuously between 50 and 60 bits per minute. The first day after the operation, when the pain and fear of movement are the most intense, therefore, the interventions are performed in two times with an interval of twelve hours at 9 am and 9 pm in the surgical department for 20 minutes.
Category
Rehabilitation
3
Description
Control group: In the control group, participants will receive only routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein (AS) Shahroud Hospital
Full name of responsible person
Mobin Mottahedi
Street address
Imam Hossein (AS) Shahrood Hospital, Imam St., at the end of 28 meters of Ayat A... Tawhidi, Shahrood
City
Shahroud
Province
Semnan
Postal code
۳۶۱۶۹۵۱۸۳۵
Phone
+98 23 3234 2000
Email
imamhosein@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ali Abbasi
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
majid bagheri
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Others
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3251 2173
Email
majidbagheri.96913@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
majid bagheri
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Others
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
shahroud
Province
Semnan
Postal code
3655117701
Phone
+98 23 3251 2173
Email
majidbagheri.96913@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
majid bagheri
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Others
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
shahroud
Province
Semnan
Postal code
3655117701
Phone
+98 23 3251 2173
Email
majidbagheri.96913@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD