Clinical trial NCT04676932: Hysterosalpingography and Comfort Theory
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory in Reducing Pain and Comfort on Women Undergoing Hysterosalpingography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type of intervention, testing the comfort and components of women undergoing Hysterosalpingography with Nursing Care Based on Kolcaba's Comfort Theory
Primary purpose: SUPPORTIVE_CARE

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)

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Being illiterate
2. Being under the age of 18
3. Having a diagnosed psychiatric illness
4. Having mental deficiency and communication problems
5. Finding drug sensitivity and allergy
6. Diagnosing secondary infertility
7. Having an active genital infection
8. The absence of a mobile phone with the ability to receive and play video messages

Primary outcomes:
measure: Visual Analog Scale(VAS)
timeFrame: 10 minutes
measure: General Comfort Questionaire (GCQ)
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
References:
citation: Krinsky R, Murillo I, Johnson J. A practical application of Katharine Kolcaba's comfort theory to cardiac patients. Appl Nurs Res. 2014 May;27(2):147-50. doi: 10.1016/j.apnr.2014.02.004. Epub 2014 Feb 14.
citation: March A, McCormack D. Nursing theory-directed healthcare: modifying Kolcaba's comfort theory as an institution-wide approach. Holist Nurs Pract. 2009 Mar-Apr;23(2):75-80; quiz 81-2. doi: 10.1097/HNP.0b013e3181a1105b.
citation: Koehn ML. Doğum ve doğum için alternatif ve tamamlayıcı tedaviler: Kolcaba'nın bütünsel konfor teorisinin bir uygulaması. Holist Hemşirelik Uygulaması. 2000 Ekim; 15 (1): 66-77. doi: 10.1097 / 00004650-200010000-00009. PMID: 12119621.
citation: Oliveira SM, Costa KNFM, Santos KFOD, Oliveira JDS, Pereira MA, Fernandes MDGM. Comfort needs as perceived by hospitalized elders: an analysis under the light of Kolcaba's theory. Rev Bras Enferm. 2020 Oct 19;73(suppl 3):e20190501. doi: 10.1590/0034-7167-2019-0501. eCollection 2020. English, Portuguese.
citation: Wilson L, Kolcaba K. Practical application of comfort theory in the perianesthesia setting. J Perianesth Nurs. 2004 Jun;19(3):164-73; quiz 171-3. doi: 10.1016/j.jopan.2004.03.006.