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NCT Number: NCT04676932

Hysterosalpingography and Comfort Theory

Hysterosalpingography (HSG) is the radiological evaluation of the uterine cavity and tubules by giving radiopaque material from the cervical canal to the uterine cavity. HSG is an invasive procedure and is often described by women as "uncomfortable, anxiety-inducing and painful", which indicates impaired comfort .Physical, emotional, sociocultural and environmental factors contribute to the formation of this condition. Comfort Theory is a nursing model that makes it easier for the caregivers to see their problems more systematically and to plan more easily. In the literature review, no studies have been found to determine the effect of Nursing Care Based on Kolcaba's Comfort Theory in Reducing Pain and Comfort on Women Undergoing Hysterosalpingography. It was aimed to determine the effect of Nursing Care Based on Kolcaba Comfort Theory on Pain and Comfort Level in Women Undergoing Hysterosalpingography Procedure.

Method. The universe of the research will form women applying for hysterosalpingography procedure in Turkey's northern province of the Health Research and Application Center between. The sample size to be taken from the universe was determined by power analysis based on the reference values of a similar study in the literature. According to the Power analysis, it was decided to include a total of 126 women, including 42 women, in each group (Control group, Intervention 1: Mobile-assisted education and counseling group, Intervention 2: Virtual reality glasses group). In this study, standard nursing care will be applied to the control group, and nursing care based on Kolcaba's Comfort Theory will be applied to the intervention groups.The data will be collected with the Visual Analog Scale(VAS) and General Comfort Questionnaire (GCQ)

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Key information

Conditions

Nursing Caries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, Atakum, 55200, Turkey (Türkiye)

About this study

In this study, Nursing care based on Kolcaba's Comfort Theory will be applied for women undergoing HSG. Before the HSG , the women will be met at the appointment time and the women will be given care during the procedure.Up to 15 minutes after the procedure will be with women. There will be 2 intervention groups and one control group. In the first intervention group, virtual reality glasses will be applied during the procedure, Mobile-assisted education and consultancy will be provided in the 2nd intervention group. This mobile assisted education and consultancy starts 48 hours before HSG shooting.The hsg capture will continue until it ends. Hospital care standards will be applied to the control group, the third group.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Volunteering to participate in research
  • Being over 18 years old
  • To be at least a primary school graduate
  • To be able to read and write Turkish
  • Not having a diagnosed psychiatric disease
  • No mental deficiency and communication problems.
  • Drug sensitivity and lack of allergy
  • Regular menstrual cycle
  • Getting a diagnosis of primary infertility
  • Not having received infertility treatment before
  • Having a mobile phone capable of receiving and playing video messages

Exclusion criteria

  • Being illiterate
  • Being under the age of 18
  • Having a diagnosed psychiatric illness
  • Having mental deficiency and communication problems
  • Finding drug sensitivity and allergy
  • Diagnosing secondary infertility
  • Having an active genital infection
  • The absence of a mobile phone with the ability to receive and play video messages

Treatment and study plan

Nursing Care Based on Kolcaba's Comfort Theory

Other

In this study, Nursing care based on Kolcaba's Comfort Theory will be applied for women undergoing HSG.

Other names: Comfort-oriented care , Mobile-assisted education and counselling, virtual reality glasses

Primary outcomes

  1. Visual Analog Scale(VAS)

    Time frame: 10 minutes

    After completing the HSG procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS). Patients indicated the maximum pain intensity experienced during the HSG by making a vertical line on the VAS.

    A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.

  2. General Comfort Questionaire (GCQ)

    Time frame: 30 minutes

    The scale, which was developed by Katharine Kolcaba in 1992 in order to determine the comfort needs of individuals, to evaluate the nursing initiatives that can provide comfort and the increase in comfort, was adapted to Turkish society by Kuğuoğlu and Karabacak in 2004.The scale, which is a four-point Likert-type scale with 48 items, was created by guiding the taxonomic structure consisting of the theoretical components of comfort, including 3 levels and 4 dimensions. Level; While the dimension is evaluated as relief (16 items), relief (17 items) and overcoming the problems (15 items); It is evaluated in three parts: physical (12 items), psychospritual (13 items) and socio-cultural (10 items). Negative expressions in the scale are calculated by reverse coding during the evaluation phase. While the lowest total score that can be obtained from the scale is 48, the highest total score is 192.

Sponsors and collaborators

Lead sponsor

Sümeyye BAL

Other

Registry information

Official study title

The Effect of Nursing Care Based on Kolcaba's Comfort Theory in Reducing Pain and Comfort on Women Undergoing Hysterosalpingography

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2020
Registry last updated
Feb 3, 2022

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.

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