Neuman Systems Model and Infertility Stress

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Intrauterine Insemination
• Intervention / Treatment: Other: Education

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara University Fertility Diagnosis, Treatment, Research and Application Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	Other: Education; NEUMAN SYSTEMS MODEL BASED NURSING APPROACH; Other Names: Relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): October 19, 2020
• Study Completion (Actual): October 19, 2020

Study Registration Dates

• First Submitted: February 28, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 16726501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No