Hysterosalpingography and Comfort Theory

NCT04676932 | Completed

• 1 other identifier: 2020/41
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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)

Conditions

Nursing Caries

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale(VAS)

  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.

  10 minutes

• General Comfort Questionaire (GCQ)

  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.

  30 minutes

Study Arms (2)

Nursing Care Based on Kolcaba's Comfort Theory

EXPERIMENTAL

In this study, nursing care based on Kolcaba's Comfort Theory will be applied to the intervention groups. Care will given when women after receiving the HSG attendance appointment. Care will terminated on the 15 minutes after the end of HSG undergoing. The time of the study 1-3 days for each women. Intervention Nursing Care Based on Kolcaba's Comfort Theory

Other: Nursing Care Based on Kolcaba's Comfort Theory

Routine hospital schedule

NO INTERVENTION

The researcher sincerely answered all questions asked by the control group during the HSG period.

Interventions

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.

Also known as: Comfort-oriented care , Mobile-assisted education and counselling, virtual reality glasses

Nursing Care Based on Kolcaba's Comfort Theory

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women Undergoing Hysterosalpingography
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sümeyye BAL: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 24637106 BACKGROUND

• 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.

  PMID: 19258847 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33084827 BACKGROUND

• 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.

  PMID: 15195275 BACKGROUND

• Bal S, Kulakac O. Effect of comfort theory-based nursing care on pain and comfort in women undergoing hysterosalpingography: a randomized controlled trial. Rev Assoc Med Bras (1992). 2023 Oct 30;69(12):e20230798. doi: 10.1590/1806-9282.20230798. eCollection 2023.

  PMID: 37909532 DERIVED

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: participant women, care provider and Outcomes Assessor
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Type of intervention, testing the comfort and components of women undergoing Hysterosalpingography with Nursing Care Based on Kolcaba's Comfort Theory

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 21, 2020
• Study Start: September 15, 2020
• Primary Completion: April 26, 2021
• Study Completion: April 27, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)