Clincosm LogoSign in Get a demo

Neuman Systems Model and Infertility Stress

Sponsor
Ankara University (Other)
Overall Status
Completed
CT.gov ID
NCT04785872
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
10.1
Actual Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, it is aimed to determine the effect of Neuman Systems Model based nursing approach on stress an coping with stress for women received intrauterine insemination (IUI) treatment. The study has been planned as a single blind experimental study in pretest-posttest design with randomized control. Sample group is going to be chosen from women who have taken IUI treatment in Ankara University Fertility Diagnosis, Treatment, Research and Application Center. Sample size of the study has been determined as 72 such that intervention=36 and control=36. While gathering data, personal information form, The COMPI Fertility Problem Stress Scales and The COMPI Coping Strategy Scales are going to be used. In the scope of the study, four interviews with women in intervention group are going to be done during IUI treatment.

Condition or Disease Intervention/Treatment Phase
  • Other: Education
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
EFFECT OF NEUMAN SYSTEMS MODEL BASED NURSING APPROACH ON STRESS AND COPING WITH STRESS FOR WOMEN RECEIVED INTRAUTERIN INSEMINATION TREATMENT
Actual Study Start Date :
Dec 17, 2019
Actual Primary Completion Date :
Oct 19, 2020
Actual Study Completion Date :
Oct 19, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Other: Education
NEUMAN SYSTEMS MODEL BASED NURSING APPROACH
Other Names:
  • Relaxation

    		•
    No Intervention: Control group

    Outcome Measures

    Primary Outcome Measures

    1. The COMPI Fertility Problem Stress Scale [Immediately after intrauterine insemination procedure]

      The scale is used for the assessment of the levels of stress experienced by infertile couples. As a Likert-type scale, it has three sub-scales in relation to personal, marital and social domains and contains a total of 14 items. 'Stress in personal domain' sub-scale contains six items, and the minimum and maximum scores to be obtained from it are successively 0 and 20 points. 'Stress in marital domain' sub-scale has four items, and the minimum and maximum scores to be obtained from it are successively 0 and 14 points. 'Stress in social domain' sub-scale is comprised of four items, and the minimum and maximum scores to be obtained from it are successively 0 and 12 points. A high score to be obtained from the sub-scale refers to the increase in the stress level.

    2. The COMPI Coping Strategy Scale [Immediately after intrauterine insemination procedure]

      The scale contains 19 items and has four sub-scales. The minimum and maximum scores to be obtained from the sub-scale of 'active-avoidance' coping method which is comprised of four items are successively 4 and 16 points. The sub-scale of 'active-confronting' coping method contains seven items. The minimum and maximum scores to be obtained from this sub-scale are successively 7 and 26 points. The minimum and maximum scores to be obtained from the sub-scale of 'passive-avoidance' coping method which is comprised of three items are successively 3 and 12 points. The sub-scale of 'meaning-based' coping method contains five items. The minimum and maximum scores to be obtained from this sub-scale are successively 5 and 20 points. A higher score to be obtained from the subscale means that the method is used more when coping with with stress.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Getting a diagnosis of primary infertility

    2. Volunteering to participate in the study

    3. Being over the age of 18

    4. Taking IUI treatment

    5. Not being diagnosed with a chronic disease

    6. Not being diagnosed with a psychiatric illness

    7. Do not have a problem that can interfere with written and verbal communication.

    Exclusion Criteria:

    1. To want to leave the study,

    2. Cancellation of treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara University Fertility Diagnosis, Treatment, Research and Application Center Ankara Turkey

    Sponsors and Collaborators

    • Ankara University

    Investigators

    • Study Chair: Menekşe N Aker, PhD, Ankara University Nursing Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Menekşe Nazlı AKER, Lecturer, Ankara University
    ClinicalTrials.gov Identifier:
    NCT04785872
    Other Study ID Numbers:
    • 16726501
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Mar 8, 2021
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Mar 8, 2021