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Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction

Primary Purpose

Fertility Issues

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Collaborative infertility counseling
Sponsored by
Port Said University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fertility Issues

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Mansoura University hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

women cases

women control

Arm Description

Outcomes

Primary Outcome Measures

Coping strategies
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).
Marital Satisfaction
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).

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
December 17, 2022
Sponsor
Port Said University
Collaborators
Mansoura University, Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT05658848
Brief Title
Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction
Official Title
Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction Among Women Undergoing in Vitro Fertilization: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Port Said University
Collaborators
Mansoura University, Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Effect of collaborative infertility counseling on coping strategies and marital satisfaction among women undergoing in vitro fertilization: a randomized control trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Issues

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
women cases
Arm Type
Experimental
Arm Title
women control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Collaborative infertility counseling
Other Intervention Name(s)
Counseling
Intervention Description
Collaborative infertility counseling for coping stratigies and marital satisfaction
Primary Outcome Measure Information:
Title
Coping strategies
Description
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).
Time Frame
Three Months
Title
Marital Satisfaction
Description
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).
Time Frame
Three Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Zoromba, PhD
Phone
0201008388226
Email
zromba2010@mans.edu.eg
Facility Information:
Facility Name
Mansoura University hospitals
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Zoromba, PhD
Phone
0201008388226
Email
zromba2010@mans.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction

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