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Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction

Sponsor
Port Said University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05658848
Collaborator
Mansoura University (Other), Prince Sattam Bin Abdulaziz University (Other)
68
Enrollment
1
Location
2
Arms
5
Anticipated Duration (Months)
13.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Collaborative infertility counseling
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction Among Women Undergoing in Vitro Fertilization: A Randomized Control Trial
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: women cases

Other: Collaborative infertility counseling
Collaborative infertility counseling for coping stratigies and marital satisfaction
Other Names:
  • Counseling

    		•
    No Intervention: women control

    Outcome Measures

    Primary Outcome Measures

    1. Coping strategies [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).

    2. Marital Satisfaction [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mansoura University hospitals Mansoura Egypt

    Sponsors and Collaborators

    • Port Said University
    • Mansoura University
    • Prince Sattam Bin Abdulaziz University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Ali Abdelsattar Zoromba, Principal Investigator, Port Said University
    ClinicalTrials.gov Identifier:
    NCT05658848
    Other Study ID Numbers:
    • P.0335
    First Posted:
    Dec 21, 2022
    Last Update Posted:
    Dec 21, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Dec 21, 2022