Nursing CariesNCT04676932
Hysterosalpingography and Comfort Theory
A study testing Nursing Care Based on Kolcaba's Comfort Theory in people with Nursing Caries, run by Sümeyye BAL at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Nursing Care Based on Kolcaba's Comfort Theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2020to 27 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55200
About this study
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory in Reducing Pain and Comfort on Women Undergoing Hysterosalpingography
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)
Read the 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.
- Conditions
- Nursing Caries
- Being tested
- Nursing Care Based on Kolcaba's Comfort Theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Care Based on Kolcaba's Comfort TheoryOther
Also called Comfort-oriented care , Mobile-assisted education and counselling, virtual reality glasses
In this study, Nursing care based on Kolcaba's Comfort Theory will be applied for women undergoing HSG.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start15 Sep 2020
- Primary completion26 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Type of intervention, testing the comfort and components of women undergoing Hysterosalpingography with Nursing Care Based on Kolcaba's Comfort Theory
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sümeyye BAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümeyye BAL, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676932
- Sponsor's protocol ID
- 2020/41
- Status last verified
- Feb 2022
- First submitted
- 30 Nov 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24637106March 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.
PubMed 19258847Koehn 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.
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.
PubMed 33084827Wilson 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.
PubMed 15195275Bal 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.
PubMed 37909532
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Care Based on Kolcaba's Comfort Theory in Reducing Pain and Comfort on Women Undergoing Hysterosalpingography
- ClinicalTrials.gov ID
- NCT04676932
- Acronym / sponsor ID
- 2020/41
- Conditions
- Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sümeyye BALUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Type of intervention, testing the comfort and components of women undergoing Hysterosalpingography with Nursing Care Based on Kolcaba's Comfort Theory
| Arm | Type | Receives |
|---|---|---|
| Nursing Care Based on Kolcaba's Comfort Theory | Experimental | Other: Nursing Care Based on Kolcaba's Comfort TheoryIn 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 |
| Routine hospital schedule | No intervention | –The researcher sincerely answered all questions asked by the control group during the HSG period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- Being illiterate
- Being under the age of 18
- Having a diagnosed psychiatric illness
- Having mental deficiency and communication problems
- Finding drug sensitivity and allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing Care Based on Kolcaba's Comfort TheoryAlso: Comfort-oriented care , Mobile-assisted education and counselling, virtual reality glassesIn this study, Nursing care based on Kolcaba's Comfort Theory will be applied for women undergoing HSG. | Other | Nursing Care Based on Kolcaba's Comfort Theory |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Background: PubMed 24637106Krinsky 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.
- Background: PubMed 19258847March 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.
- BackgroundKoehn 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: PubMed 33084827Oliveira 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.
- Background: PubMed 15195275Wilson 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.
- Derived from this study: PubMed 37909532Bal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Care Based on Kolcaba's Comfort Theory in people with Nursing Caries, run by Sümeyye BAL at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale(VAS) (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04676932, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.