Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-30 @ 12:21 AM
Study NCT ID:
NCT04676932
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hysterosalpingography and Comfort Theory
Sponsor:
Sümeyye BAL
Organization:
Study Overview
Official Title:
The Effect of Nursing Care Based on Kolcaba's Comfort Theory in Reducing Pain and Comfort on Women Undergoing Hysterosalpingography
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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)
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)
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: