Back to resultsNeuman Systems Model and Infertility Stress
Primary Purpose
Infertility, Intrauterine Insemination
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Getting a diagnosis of primary infertility
- Volunteering to participate in the study
- Being over the age of 18
- Taking IUI treatment
- Not being diagnosed with a chronic disease
- Not being diagnosed with a psychiatric illness
- Do not have a problem that can interfere with written and verbal communication.
Exclusion Criteria:
- To want to leave the study,
- Cancellation of treatment.
Sites / Locations
- Ankara University Fertility Diagnosis, Treatment, Research and Application Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Outcomes
Primary Outcome Measures
The COMPI Fertility Problem Stress Scale
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.
The COMPI Coping Strategy Scale
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04785872
Brief Title
Neuman Systems Model and Infertility Stress
Official Title
EFFECT OF NEUMAN SYSTEMS MODEL BASED NURSING APPROACH ON STRESS AND COPING WITH STRESS FOR WOMEN RECEIVED INTRAUTERIN INSEMINATION TREATMENT
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
October 19, 2020 (Actual)
Study Completion Date
October 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Intrauterine Insemination
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Education
Other Intervention Name(s)
Relaxation
Intervention Description
NEUMAN SYSTEMS MODEL BASED NURSING APPROACH
Primary Outcome Measure Information:
Title
The COMPI Fertility Problem Stress Scale
Description
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.
Time Frame
Immediately after intrauterine insemination procedure
Title
The COMPI Coping Strategy Scale
Description
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.
Time Frame
Immediately after intrauterine insemination procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Getting a diagnosis of primary infertility
Volunteering to participate in the study
Being over the age of 18
Taking IUI treatment
Not being diagnosed with a chronic disease
Not being diagnosed with a psychiatric illness
Do not have a problem that can interfere with written and verbal communication.
Exclusion Criteria:
To want to leave the study,
Cancellation of treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menekşe N Aker, PhD
Organizational Affiliation
Ankara University Nursing Faculty
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara University Fertility Diagnosis, Treatment, Research and Application Center
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuman Systems Model and Infertility Stress
We'll reach out to this number within 24 hrs