Neuman Systems Model and Infertility Stress

Infertility Clinical Trial

Official title:

EFFECT OF NEUMAN SYSTEMS MODEL BASED NURSING APPROACH ON STRESS AND COPING WITH STRESS FOR WOMEN RECEIVED INTRAUTERIN INSEMINATION TREATMENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785872
• Other study ID #: 16726501
• Status: Completed
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: October 19, 2020

Study information

• Verified date: May 2023
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 19, 2020
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Intrauterine Insemination

Intervention

Other:
• Education
NEUMAN SYSTEMS MODEL BASED NURSING APPROACH

Locations

Country	Name	City	State
Turkey	Ankara University Fertility Diagnosis, Treatment, Research and Application Center	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after intrauterine insemination procedure
Primary	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.	Immediately after intrauterine insemination procedure