A comparative study of the effect of relaxation technique and acupressure on stress, anxiety and depression of polycystic ovary syndrome in the community of girls
Determining and comparing the average stress، anxiety and depression score in girls with polycystic ovary syndrome before and after the intervention
Design
A three-group and multi-species clinical trial with two intervention groups and one control group, with a parallel group, three-way blind randomized on 105 patients.
Settings and conduct
After obtaining permission to enter the dormitory and receiving a letter of introduction to attend the dormitories of Isfahan and Isfahan Universities of Medical Sciences, the researcher refers to the desired dormitories.
Participants/Inclusion and exclusion criteria
1)Proficient in Persian language 2) age 18 to 45 years3) Single4) Not suffering from chronic psychological diseases under treatment5)Confirmation of polycystic ovary syndrome by a gynecologist or endocrinologist6)Not participating in activities such as music, sports or individual and group counseling to reduce stress, anxiety and depression7)At most 3 to 6 months have passed since the diagnosis of the disease.
8)They have not been involved in stressful problems and unfortunate life events such as the loss of a loved one, divorce, marriage or migration in the last 3 to 6 months.
Intervention groups
Relaxtion technique in this research is a combination of Jacobson and Benson techniques. These techniques are in the form of muscle contraction and then releasing them and a kind of positive imagery that the participants use all their senses to understand this hypothetical environment. Acupressure technique is performed on Hugo points, Hart point 7 (H7), Lu7 point, P6 point, K1 point and LI4 point. The control group is provided with an educational pamphlet on how to reduce stress, anxiety and depression.
Main outcome variables
Relaxation group, acupressure group and control group (independent variable)
Stress, anxiety and depression (dependent variable)
General information
Reason for update
Acronym
Esfpocos
IRCT registration information
IRCT registration number:IRCT20150624022896N4
Registration date:2024-08-19, 1403/05/29
Registration timing:prospective
Last update:2024-08-19, 1403/05/29
Update count:0
Registration date
2024-08-19, 1403/05/29
Registrant information
Name
Maryam Kianpour
Name of organization / entity
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3320 6595
Email address
kianpour@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of relaxation technique and acupressure on stress, anxiety and depression of polycystic ovary syndrome in the community of girls
Public title
A comparative study of the effect of relaxation technique and acupressure on stress, anxiety and depression of polycystic ovary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Proficiency in persian language
18-45 years old
single
Confirmation of polycystic ovary syndrome by a gynecologist or endocrinologist
At most 3 to 6 months have passed since the diagnosis of the disease.
They have not been involved in stressful problems and unfortunate life events such as the loss of a loved one, divorce, marriage or migration in the last 3 to 6 months.
Exclusion criteria:
Having a chornic psychological disease under treatment
Participating in activities such as music, sports or individual and group counseling to reduce stress, anxiety and depression
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
For sampling, we first consider the dormitories of Isfahan University of Medical Sciences and Isfahan University. In each dormitory building, taking into account the number of each unit (or room), the dormitory units are selected by systematic random sampling, and if possible, 1 qualified person is selected from each unit.The girls who enter the study are assigned to two intervention groups and one control group using permutation blocks. Random sequence is determined using R 3.5.2 software and blockrand package.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, after preparing the final list of participants based on the study entry criteria, the researcher divides the girls into three groups: intervention 1 (relaxation tone), intervention 2 (acupressure) and control.And in this way, the participants (if needed, the clinical caregiver) and the researcher are kept blind to the grouping of people in the study.After data collection, the outcome assessor and data analyst, as well as the data monitoring committee, are kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Medicine - Isfahan University of Medical Sciences
Street address
Hazar Jarib Ave., Isfahan University of Medical Sciences and Health Services, Central Headquarters
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
IR.MUI.MED.REC.1403.142
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Average score of depression using DASS 21 questionnaire
Timepoint
Measuring the average score of depression before the intervention and 6 sessions after the intervention
Method of measurement
DASS 21 questionnaire
2
Description
Average stress score using DAS 21 questionnaire
Timepoint
Measuring the average stress score before the intervention and 6 sessions after the intervention
Method of measurement
DASS 21 questionnaire
3
Description
Average anxiety score using DAS 21 questionnaire
Timepoint
Measuring the average score of anxiety before the intervention and 6 sessions after the intervention
Method of measurement
DASS 21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intervention group 1 (relaxtion group): In this research relaxtion technique is a combination of Jacobson and Benson techniques.Jacobson's technique, or progressive muscle tone, will take place in the form of muscle contraction and then their release.Benson's technique is actually a type of positive imagery where participants imagine themselves in an environment by listening to the researcher's words, using all their senses (sight, smell, hearing, taste, touch) to understand the hypothetical environment. And in this way they will release their tensions.This technique will be done in groups of 10-15 people in dormitories that are closer to each other.
Category
Lifestyle
2
Description
Intervention group: intervention group 2 (acupressure): Acupressure technique on the points of Hugo points (between the first and second metacarpals), Hart point 7 (H7) (at the inner end of the transverse line of the wrist), Lu7 point (in the radial part of the forearm, above the styloid appendage of Zabrin at the distance 5 cm from the transverse crease of the wrist), point P6 (at a distance of 5 cm from the transverse line of the wrist), point K1 (in the middle of the sole between the upper third and lower two thirds) and point LI4 (in the radial depression) The hand is performed at the middle point of the second metacarpal bone of the palm.The rate of pressing these points is 2 minutes for each point and teaching these points to press them at home.This technique is performed every 4 days for 5 to 6 sessions for 3 weeks. This technique is done individually, and to do this technique, the necessary training is done by referring to each person's room in the dormitory, and people are also taught to do it three times at home for ten minutes.
Category
Lifestyle
3
Description
Control group: For girls in the control group, an educational pamphlet is provided on how to reduce stress, anxiety and depression.It should be noted that in the 3 studied groups, the routine treatment of girls is not removed and in addition to the treatment, interventions are performed in two groups.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls dormitories of Isfahan University of Medical Sciences
Full name of responsible person
Zahra Jamali
Street address
Hazar Jarib Ave., Isfahan University of Medical Sciences and Health Services, Central Headquarters
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
kianpour@mail.mui.ac.ir
2
Recruitment center
Name of recruitment center
Girls' dormitories of Isfahan University
Full name of responsible person
Zahra Jamali
Street address
Isfahan, Azadi Square, Isfahan University
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Email
kianpour@mail.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Hazar Jarib Ave., Isfahan University of Medical Sciences and Health Services, Central Headquarters
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
kianpour@mail.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Kianpour-Zahra Jamali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hazar Jarib Ave., Isfahan University of Medical Sciences and Health Services, Central Headquarters
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
kianpour@mail.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Kianpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hazar Jarib Ave., Isfahan University of Medical Sciences and Health Services, Central Headquarters
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
kianpour@mail.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam kianpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hazar Jarib Ave., Isfahan University of Medical Sciences and Health Services, Central Headquarters
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
kianpour@mail.mui.ac.ir
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