- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05658848
Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction
December 17, 2022 updated by: Mohamed Ali Abdelsattar Zoromba, Port Said University
Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction Among Women Undergoing in Vitro Fertilization: A Randomized Control Trial
Effect of collaborative infertility counseling on coping strategies and marital satisfaction among women undergoing in vitro fertilization: a randomized control trial
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Zoromba, PhD
- Phone Number: 0201008388226
- Email: zromba2010@mans.edu.eg
Study Locations
-
-
-
Mansoura, Egypt
- Recruiting
- Mansoura University hospitals
-
Contact:
- Mohamed Zoromba, PhD
- Phone Number: 0201008388226
- Email: zromba2010@mans.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 41 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
This study will include a non-probability purposive sample of 136 infertile women undergoing IVF recruiting from the outpatient clinics according to the following inclusion criteria:
- age 20 to 45 years
- having a general health score below 28,
- can read and write,
Exclusion criteria include:
- psychiatric problems,
- previous assisted reproductive technology failure,
- leave the intervention for any reason and
- women suddenly experience severe traumatic or psychological events.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: women cases
|
Collaborative infertility counseling for coping stratigies and marital satisfaction
Other Names:
|
|
No Intervention: women control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coping strategies
Time Frame: Three Months
|
The Ways of Coping-Revised (WOC-R) questionnaire will be adopted from Folkman, Lazarus, Pimley, & Novacek, (1987) to evaluate women coping styles.
It contains 31 items and 8 subscales graded by a 3-point Likert scale.
It is divided into problem-focused and emotion-focused coping strategies.
The problem-focused strategy includes 4 subscales: planful problem solving, seeking social support, accepting responsibility, and positive reappraisal.
The emotional-focused coping strategy includes 4 subscales: confrontive coping, self-controlling, distancing, and escape/avoidance.
The responses will be rated on a 3-point scale (0 = didn't use to 2 = used all the time).
|
Three Months
|
|
Marital Satisfaction
Time Frame: Three Months
|
The Marital Satisfaction Index (MSI) was developed by Cheung & Hudson, (1982) to measure the degree of marital satisfaction.
It consists of 25 items of which 13 are positively worded and 12 are negatively worded.
The responses will be rated on a 5-point Likert scale (1 = None of the time, 2 = Very rarely, 3 = Sometimes, 4 = Most of the time, and 5 = All the time).
The minimum and maximum scores of the MSI are 25 and 75, respectively.
The higher score (above 30) indicates women's dissatisfaction.
The GHQ-28 and FPI will be used to assess women's general health and perceived fertility-related stress respectively (Goldberg & Hillier, 1979; Sherrard, Newton, & Glavac, 1999).
|
Three Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
April 1, 2023
Study Registration Dates
First Submitted
December 9, 2022
First Submitted That Met QC Criteria
December 17, 2022
First Posted (Actual)
December 21, 2022
Study Record Updates
Last Update Posted (Actual)
December 21, 2022
Last Update Submitted That Met QC Criteria
December 17, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.0335
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.