Examining the effect of progressive muscle relaxation technique on postoperative pain, sleep quality, and anxiety in hospitalized patients with hip fractures
Determining the effect of progressive muscle relaxation on the amount of pain, sleep quality and anxiety of hospitalized patients with hip fracture
Design
The study is a one-blind clinical trial study conducted on 100 patients with hip fractures eligible to enter the study and assigned randomly individual assigned to the intervention group (50 people) and control group (50 people) using coin toss. Intervention is a progressive muscle relaxation technique that will be performed for three consecutive nights starting tomorrow night after surgery.
Settings and conduct
The study will be conducted at Shohaie_Haftome_Tir hospital, Tehran. The study is a one-blinded and participants will not be informed about group assignment. Participants were assigned to the intervention group (50 people) and control (50 people) based on entry criteria and individual randomization (coin toss). The two groups were matched in terms of receiving pain relief, and all of them will receive Apotel painkillers as directed by the doctor.The progressive muscle relaxation technique started the night after the surgery and will continue for three days. The intervention will be implemented by the first researcher.The data will be measured in two phases including before the intervention and one day after the intervention is completed.
Participants/Inclusion and exclusion criteria
Confirmed hip fracture; Age 40-65; Hospitalization for at least 5 days; Not having multiple fractures in the limbs; Having literacy; Not using sleeping pills, antidepressants, and psychosis; Not having dementia; No drug addiction
Intervention groups
Progressive muscle relaxation technique for intervention group participants started one night after surgery and will continue for three consecutive nights. The control group will not receive such an intervention.
Main outcome variables
Postoperative pain; Sleep quality; Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231120060119N1
Registration date:2023-12-07, 1402/09/16
Registration timing:prospective
Last update:2023-12-07, 1402/09/16
Update count:0
Registration date
2023-12-07, 1402/09/16
Registrant information
Name
Sahar Mashhadinaser
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5598 3306
Email address
sahari77.naseri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the effect of progressive muscle relaxation technique on postoperative pain, sleep quality, and anxiety in hospitalized patients with hip fractures
Public title
Effect of progressive muscle relaxation technique on postoperative pain sleep quality, and anxiety in hospitalized patients with hip fractures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of hip fractures (based on the diagnosis of an orthopedic specialist in the medical record)
age 40-65
No multiple trauma or fracture of both upper and lower limbs
Being literate in reading and writing
No use of sleeping, sedative anti-depressant, or psychotic drugs in the last 2 months
No serious dementia or cognitive dysfunction (based on the patient's or his family's self-report)
No drug addiction
Exclusion criteria:
Dissatisfaction to enter the study
Hospitalization less than 5 days
Hospitalization less than 48 hours from admission
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Hip fracture patients who are eligible will be assigned to intervention and control groups by individual randomness and using coin toss (lion/line). This sampling process continues until at least 50 people enter each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer is not aware of which of the two intervention or control groups the data belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Vali-Asr Street
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2023-02-12, 1401/11/23
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.724
Health conditions studied
1
Description of health condition studied
Hip fracture
ICD-10 code
M80-M85
ICD-10 code description
Disorders of bone density and structure
Primary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention, one day after the completion of the intervention
Method of measurement
Numerical rating scale for pain
2
Description
Sleep quality
Timepoint
The Pittsburgh Sleep Quality Index
Method of measurement
Before the intervention, one day after the completion of the intervention
3
Description
Anxiety
Timepoint
Before the intervention, one day after the completion of the intervention
Method of measurement
The State-Trait Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: the group will receive progressive muscle relaxation from the next day of surgery for three nights, while the last meal has been at least three hours. Each time, the process will take about 30 minutes. At the stage of preparation for the technique, the room's environment will be calmed down, and environmental stimuli will be minimized. The trainee participant will be asked to go to the bathroom, empty his bladder, dress loosely, take off his socks and shoes, lie on his back comfortably, minimize using five senses, and close his eyes. In the implementation phase, the participant is trained to contract each muscle of the upper limbs, shoulders, head and neck, chest, abdomen, and lower limbs for 15-10 seconds, respecting the order, and then relax for 15-20 seconds. At the same time as the exercises, the participant will be taught to exhale through the nose, the deep tail, and the mouth. If the contributor starts from the left upper limb and then moves to the right limb, they can also follow this principle for other movements. Each group of muscles will train back to back three times in a row.
Category
Behavior
2
Description
Control group: will not receive any intervention in the form of progressive muscle relaxation.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Haftome_Tir hospital
Full name of responsible person
Dr Seyed Abdolhadi Daneshi
Street address
Shahid Rejaee Street
City
Tehran
Province
Tehran
Postal code
252634897
Phone
+98 21 5522 8582
Fax
+98 21 5521 7901
Email
web7tir@iums.ac.ir
Web page address
https://hospht.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Alireza Zali
Street address
Velenjak, Daneshjoo Boulevard, the Arabi street
City
Tehran
Province
Tehran
Postal code
88776444421
Phone
+98 21 2243 9780
Fax
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvaneh Vasli
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5367
Email
parvanehvasli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvaneh Vasli
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Streey
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5367
Email
parvanehvasli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvaneh Vasli
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5367
Email
parvanehvasli@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be kept in the form of an SPSS file with the corresponding author and made available to readers upon request. The results of the data analysis will also be published in a scientific journal.
When the data will become available and for how long
After the article was published
To whom data/document is available
Any reader of the published article who requests
Under which criteria data/document could be used
Whenever readers request.
From where data/document is obtainable
The corresponding author
What processes are involved for a request to access data/document
Send an email to the corresponding author to request the data