Skip to main content
OpenTrials
Completed

NCT Number: NCT04785872

Neuman Systems Model and Infertility Stress

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Fertility Diagnosis, Treatment, Research and Application Center

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education

Other

NEUMAN SYSTEMS MODEL BASED NURSING APPROACH

Other names: Relaxation

Primary outcomes

  1. The COMPI Fertility Problem Stress Scale

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2021
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.