Protocol summary

Study aim
evaluate the effect of JPRT on post-operative pain, activity tolerance, and sleeping quality in patients undergoing gynaecological surgery.
Design
randomized controlled clinical trial
Settings and conduct
This study will be carried out at the Obstetrics and Gynaecology Department at Damanhour Educational Institute affiliated to the ministry of health in Elbehira governorate /Egypt.
Participants/Inclusion and exclusion criteria
patients undergoing abdominal gynaecological surgery for benign conditions, being able to differentiate between the different images in visual analogue scale, being free from any psychological or mental disorders, taking non-steroidal anti-inflammatory medication as post-operative analgesia, and being enthusiastic about contributing in the study. While drug abusers, alcoholics, those who undergo laparoscopic surgery, drink more than 3 cups of coffee per day, use sleep medications, and had intra or post-operative complications will be excluded from the study.
Intervention groups
The patients in the intervention group will be explained that the technique involves the systemic sequential tension in specific muscle groups associated. Inhale deeply, then hold the breath for ten seconds. This tension is then released while exhaling from pursed lips within ten seconds slowly. Also, it will explained that the muscles of the body are divided into twelve groups: hands, biceps and triceps, shoulders, neck, mouth, jaw, eyes and forehead, chest, abdomen, back, thighs, legs, and feet muscles. The researchers will help the patient to sit comfortably in her bed from the beginning till the end of the JPRT session.
Main outcome variables
pain, activity tolerance, and sleep quality

General information

Reason for update
Acronym
JPRT
IRCT registration information
IRCT registration number: IRCT20210131050193N1
Registration date: 2021-02-07, 1399/11/19
Registration timing: prospective

Last update: 2021-02-07, 1399/11/19
Update count: 0
Registration date
2021-02-07, 1399/11/19
Registrant information
Name
Heba Ibrahim
Name of organization / entity
Benha University
Country
Egypt
Phone
+20 13 2265261
Email address
heba_esmael18@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-15, 1399/11/27
Expected recruitment end date
2021-06-15, 1400/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Jacobson’s Progressive Relaxation Technique on Postoperative Pain, Activity Tolerance and Sleeping Quality in Patients Undergoing Gynaecological Surgery
Public title
Jacobson’s Technique on Postoperative Pain, Activity Tolerance and Sleeping
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
patients undergoing abdominal gynaecological surgery for benign conditions, being able to differentiate between the different images in visual analogue scale, being free from any psychological or mental disorders, taking non-steroidal anti-inflammatory medication as post-operative analgesia, and being enthusiastic about contributing in the study.
Exclusion criteria:
Drug abusers, alcoholics, those who undergo laparoscopic surgery, drink more than 3 cups of coffee per day, use sleep medications, and had intra or post-operative complications will be excluded from the study.
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 116
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization block technique will be used to randomly assign participants to the JPRT and control group. The researchers will follow six phases to conduct the randomization block technique. First; the researches will make a list that contains numbers from 1 to 116. Second; the researchers will make small pieces of papers that contain numbers from 1 to 116. Third; the researchers will fold the paper pieces to hide the numbers written on it, then it will be put in a bowl. Fourth; the researchers will divide the 116 pieces of papers into six blocks randomly and blindly; the first five blocks will involve 20 random numbers, and the last one will involve 16 remaining numbers. Fifth; half of the numbers will be randomly and blindly selected to the JPRT group from each block, while the residual will be allocated to the control group. Sixth; the sequence of cases will be recorded in the preset list (the word JPRT or control will be written in front of each number) to be taken into consideration when collecting data.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Nursing care

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
nursing college ethical committee at Damanhur University
Street address
Ataa Al leathy street
City
Damanhour
Postal code
55461
Approval date
2019-02-02, 1397/11/13
Ethics committee reference number
02-02-02-2019 EC

Health conditions studied

1

Description of health condition studied
Patients Undergoing Gynaecological Surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Postoperative Pain, Activity Tolerance and Sleeping Quality
Timepoint
before intervention and 2, days after intervention
Method of measurement
pain analogue scale; activity tolerance questionnaire, and the Groningen sleeping quality scale.

Secondary outcomes

1

Description
None
Timepoint
None
Method of measurement
None

Intervention groups

1

Description
Intervention group:
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Obstetrics and Gynecology Department/Damanhour educational institute, Elbehira, Egypt.
Full name of responsible person
wafaa Elgzar
Street address
AlOrgan street
City
Damanhour
Postal code
55461
Phone
+20 13 2261265
Email
heba_esmael18@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Damanhour University
Full name of responsible person
wafaa Taha Elgzar
Street address
AlOrgan street
City
Damanhour
Postal code
55461
Phone
+20 13 2465461
Email
wafaa.elgzar@nur.dmu.edu.eg
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Damanhour University
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
Benha University
Full name of responsible person
Heba Ibrahim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tuok AlOrgan street
City
Benha
Province
Alkalubia
Postal code
013
Phone
+20 13 2265261
Email
heba_esmael18@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Benha University
Full name of responsible person
Heba Ibrahim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Alorgan street
City
Benha
Province
Alkalubia
Postal code
55461
Phone
+20 13 2465461
Email
heba_esmael18@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Benha University
Full name of responsible person
Heba Ibrahim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tuok AlOrgan street
City
Benha
Province
Alkalubia
Postal code
013
Phone
+20 13 2465461
Email
heba_esmael18@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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