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NCT04676932
Hysterosalpingography and Comfort Theory
NA trial testing Nursing Care Based on Kolcaba's Comfort Theory in Nursing Caries in 126 participants. Completed in 27 April 2021.
26 April 2021
Quick facts
| Lead sponsor | Sümeyye BAL |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 126 |
| Start date | 15 September 2020 |
| Primary completion | 26 April 2021 |
| Estimated completion | 27 April 2021 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Nursing Care Based on Kolcaba's Comfort Theory
Conditions studied
- Nursing Caries — all drugs for Nursing Caries →
Sponsor
Sümeyye BAL
Who can join
18 and older, female only, with Nursing Caries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of comfort theory-based nursing care on pain and comfort in women undergoing hysterosalpingography: a randomized controlled trial.
Bal S, Kulakaç Ö. · · 2023 · cited 3× · PMID 37909532 · DOI 10.1590/1806-9282.20230798
Verify or expand the search:
- PubMed search for NCT04676932
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nursing Care Based on Kolcaba's Comfort Theory
Trials testing the same drug.
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- NCT07050901 — Theory of Kolcaba on the Quality of Life and Psychological Well-Being Levels of the Aged People · NA · active not recruiting
- NCT05791903 — The Effect of Nursing Care Based on Kolcaba's Comfort Theory on of Intensive Care Patients · NA · completed
- NCT04105556 — Male Circumcision and Comfort Theory · NA · unknown
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Other Sümeyye BAL trials
Trials by the same sponsor.
- NCT05192343 — Effects of Virtual Reality and Nature Sounds on Pain and Anxiety During Hysterosalpingography · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04676932 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sümeyye BAL
- Last refreshed: 3 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04676932.
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