Neuman Systems Model and Infertility Stress

NCT04785872 | Completed

• 1 other identifier: 16726501
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Intrauterine Insemination

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Other: Education

Control group

NO INTERVENTION

Interventions

Education OTHER

NEUMAN SYSTEMS MODEL BASED NURSING APPROACH

Also known as: Relaxation

Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• To want to leave the study,
• Cancellation of treatment.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Fertility Diagnosis, Treatment, Research and Application Center

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Menekşe N Aker, PhD

  Ankara University Nursing Faculty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 8, 2021
• Study Start: December 17, 2019
• Primary Completion: October 19, 2020
• Study Completion: October 19, 2020
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)