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The effect of Relaxation with Guided imagery on stress in IVF candidates of infertile women

Protocol summary

Study aim
Determining the effect of Relaxation with Guided imagery on stress in IVF candidates of infertile women
Design
The present study is a randomized clinical trial. The sampling method is block randomization and participants with probabilities AABB,ABBA,ABAB,BBAA,BAAB,BABA divided into control and intervention groups.
Settings and conduct
The study population was infertile women candidates for IVF. The research environment is Arash hospital in Tehran. The experimental group will receive mentally guided imagery training for 3 weeks, twice a week, each session for 45 minutes through virtual training, but the control group will receive routine therapies. Upon completion of the research, a summary of the training will be provided to the control group. Data collection tools will include a questionnaire related to demographic information, fertility information and Newton questionnaire. The Newton questionnaire will be completed by individuals in both groups before and immediately after the intervention.
Participants/Inclusion and exclusion criteria
Ages between 18-49 years, lack of known physical or mental illness, not attending other psychotherapy courses, women IVF candidates for the first time or several times, being in the moderate stress group of the Newton Questionnaire (score 92-184) , Iranian nationality and having a minimum literacy
Intervention groups
The experimental group will receive mentally guided imagery training for 3 weeks, twice a week, each session for 45 minutes through virtual training, but the control group will receive routine therapies. Upon completion of the research, a summary of the training will be provided to the control group.
Main outcome variables
Guided imagery, stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160821029446N9
Registration date: 2021-09-03, 1400/06/12
Registration timing: registered_while_recruiting

Last update: 2021-09-03, 1400/06/12
Update count: 0
Registration date
2021-09-03, 1400/06/12
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Relaxation with Guided imagery on stress in IVF candidates of infertile women
Public title
The effect of Relaxation with Guided imagery on stress in IVF candidates of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 49-18 years Lack of known physical or mental illness Not participating in other psychotherapy courses Women candidates for IVF for the first time or several times Being in the moderate of Newton questionnaire (score 92-184) Iranian nationality Have a minimum literacy
Exclusion criteria:
Get a low or high score on the Newton Infertility Stress Questionnaire Reluctance to participate in the study
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals will be selected by available sampling and the randomization method in this study is block randomization. Samples will be randomly divided with probabilities AABB, ABBA, ABAB, BBAA, BAAB, BABA in the control and intervention groups. Then we write all the permutation combinations of the letters A, A, B and B, which are 6 different combinations, on 6 cards. Then we choose a digit at random from digits 1 to 6 (with the help of a table of random numbers or we ask patient number one to choose a card at random).For example, if the number 2 is selected, it means that the first person in the intervention group will be the next two people in the control group and the fourth person in the intervention group, and we will continue this operation until the sample size reaches the quorum
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
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nusrat),School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-06-30, 1400/04/09
Ethics committee reference number
IR.TUMS.FNM.REC.1400.065

Health conditions studied

1

Description of health condition studied
Stress in infertile women IVF candidates
ICD-10 code
O09.0
ICD-10 code description
Supervision of pregnancy with history of infertility

Primary outcomes

1

Description
stress
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Newton Infertility Stress Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The experimental group will be subjected to mentally guided imaging training for 3 weeks, twice a week, each session for 45 minutes through virtual training. The training sessions are summarized as follows: First session: Introducing the purpose of research and explanation in relation to the intervention and training. second session: Identify your misconceptions and irrational thoughts. third session: Guided imagery technique training. fourth Session: Teaching breathing techniques with healing energy balls fifth Session: Mountain meditation technique Sixth Session: Practice making love
Category
Other

2

Description
Control group: The control group will receive routine treatments. Upon completion of the research, a summary of the training will be provided to the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women's Comprehensive Hospital
Full name of responsible person
Maryam Damghanian
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square.Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
reaserch dean of Tehran University of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
No23, Dameshgh street, Valiasr street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
reaserch dean of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Samira Noorzaie
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
snoorzaie1374@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
maryamdamghanian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
maryamdamghanian@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
Data analysis will be presented in the form of findings.
Study Protocol
No - There is not 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
No - There is not 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
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