Urological NursingNCT06699173
Effect of Heat Aplication to Patients During Cystoscopy Procedure
A study testing Heat ped in people with Urological Nursing, run by Emine Karakaya at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study was planned to determine the effect of hot application, which is one of the non-pharmacological methods that can be applied to reduce pain during the Rigid Cystoscopy procedure, on pain, anxiety and comfort levels on 62 persons.As a result, it was found that there was a statistically… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Urological Nursing
- What is being tested?
- Heat ped
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Nov 2024
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Rigid (rigid) cystoscopy was performed for diagnosis and / or treatment purposes (bladder tumor).
- Does not require anesthesia. Over 18 years old No communication barrier without severe disease Cystoscopy for the first time or for control purposes İndividuals who participated in this research for the first time and agreed to participate in the research constituted the inclusion criteria.
Who cannot join
- Urinary hematuria. Urinary tract infection Overactive bladder Pelvic pain etc. A mental health disease, who had communication problems. Under 18 years of age. Anesthesia, Not agree to participate in the research were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Heat Aplication to Patients During Cystoscopy Procedure on Pain, Anxiety and Comfort Level A: Randomized Controlled Trial
This randomized controlled study was planned to determine the effect of hot application, which is one of the non-pharmacological methods that can be applied to reduce pain during the Rigid Cystoscopy procedure, on pain, anxiety and comfort levels on 62 persons.As a result, it was found that there was a statistically significant difference between the visual comparison scale scores during and after the procedure according to the participants' groups.
Read the detailed description
This study was planned to determine the effect of hot application, which is one of the non-pharmacological methods that can be applied to reduce pain during the Rigid Cystoscopy procedure, on pain, anxiety and comfort levels.
This study is a randomized controlled experimental study to determine the effect of heat application on patients' pain, anxiety and comfort levels during the cystoscopy procedure. The population of the research consisted of individuals who were hospitalized in the Cystoscopy unit of Manisa Provincial Health Directorate Merkez Efendi State Hospital between November 2023 - June 2024, and the sample consisted of individuals who met the inclusion criteriaan dagreed to participate in the research. Participants (n=62) were randomized into two groups: intervention (n=31) and control group (n=31) in a 1:1 ratio, using random numbers generated by the simple randomization method on the computer. The intervention group consisted of 5 women and 26 men, the control group consisted of 8 women and 23 men, a total of 13 women and 49 men who is over over 18 years The sample group was presented according to the CONSORT diagram. Heat application was not applied routinely to the intervention group, and unlike the intervention group, heat application was not applied only with thermophor to the control group. However, the scales and forms were evaluated and blood pressure and pulse rate were measured during the same period. Incollecting data; 'Individual Introduction Form', 'Information Form Regarding the Cystoscopy Procedure', 'Visual Comparison Scale (VAS)', 'Data Recording Form', 'State Anxiety Scale' and 'General Comfort Scale Short Form' were used.
- Conditions
- Urological Nursing
- Being tested
- Heat ped
- Keywords
- Anxiety, Confort, Cystoscopy, Heat Application, Pain, Bladder Tumor
- Medical subject headings
- Anxiety Disorders, Pain, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat pedOther
The hot ped was used during ricig cystoscopy
| Study group | Role | What they receive |
|---|---|---|
| İntervention Group | Experimental | Experimental :
Heat application was not applied routinely to the intervention group, and unlike the intervention group, heat application was not applied only with thermophor to the control group. However, the scales and forms were evaluated and blood pressure and pulse rate were measured during the same period. Incollecting data; 'Individual Introduction Form', 'Information Form Regarding the Cystoscopy Procedure', 'Visual Comparison Scale (VAS)', 'Data Recording Form', 'State Anxiety Scale' and 'General Comfort Scale Short Form' were used.
Thermophor Prosedure
Before the cystoscopy procedure, the temperature of the water was measured as 40-45°C. Approximately two-thirds of the bag was filled with hot water and the air in the bag was removed. The bag was dried and checked for leakage, then wrapped with the bag's cover and placed on the patient's lower abdomen body area 5 minutes before the cystoscopy procedure. Receives: Other: Heat ped |
| Control Group | No intervention | The scales and forms were evaluated and blood pressure and pulse rate were measured during the same period. Incollecting data; 'Individual Introduction Form', 'Information Form Regarding the Cystoscopy Procedure', 'Visual Comparison Scale (VAS)', 'Data Recording Form', 'State Anxiety Scale' and 'General Comfort Scale Short Form' were used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain due to rigid cystoscopy
Vusiel analog scale was used(VAS, 0(good) - 10cm (worse)
Measured: 20 minutes
Anxiety due to rigid cystoscopy
The state anxiety scale scores .The highest score is 80 (worse) and the lowest score is 20(good).
Measured: 5 minutes
Confort levels due to rigid cystoscopy
General Comfort Scale Short Form (28(worse) -168(good)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Nov 2023
- Primary completion15 Jun 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urological NursingStudies 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
- Sequential
- Model description
- randomize two grup intervention and control grup
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emine Karakaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emine Karakaya, Manisa Celal Bayar University
- Investigators
- Kıvan Çevik Kaya, Principal investigator, Manisa Celal Bayar Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699173
- Sponsor's protocol ID
- 221346001,CelalBayarU
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be given if it's necessary it is not problem for ethical office
Publications
Seklehner S, Engelhardt PF, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Wehrberger C, Librenjak D, Hubner W, Breinl E, Riedl C. Anxiety and depression analyses of patients undergoing diagnostic cystoscopy. Qual Life Res. 2016 Sep;25(9):2307-14. doi: 10.1007/s11136-016-1264-z. Epub 2016 Mar 17.
PubMed 26984467Kim SB, Yoon SG, Tae J, Kim JY, Shim JS, Kang SG, Cheon J, Lee JG, Kim JJ, Kang SH. Detection and recurrence rate of transurethral resection of bladder tumors by narrow-band imaging: Prospective, randomized comparison with white light cystoscopy. Investig Clin Urol. 2018 Mar;59(2):98-105. doi: 10.4111/icu.2018.59.2.98. Epub 2018 Feb 8.
PubMed 29520385Kwon OS, Kwon B, Kim J, Kim BH. Effects of Heating Therapy on Pain, Anxiety, Physiologic Measures, and Satisfaction in Patients Undergoing Cystoscopy. Asian Nurs Res (Korean Soc Nurs Sci). 2022 May;16(2):73-79. doi: 10.1016/j.anr.2022.02.002. Epub 2022 Feb 20.
PubMed 35196580Casteleijn NF, Vriesema JL, Stomps SP, van Balen OL, Cornel EB. The effect of office based flexible and rigid cystoscopy on pain experience in female patients. Investig Clin Urol. 2017 Jan;58(1):48-53. doi: 10.4111/icu.2017.58.1.48. Epub 2017 Jan 4.
PubMed 28097268
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heat Aplication to Patients During Cystoscopy Procedure on Pain, Anxiety and Comfort Level A: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06699173
- Acronym / sponsor ID
- 221346001,CelalBayarU
- Conditions
- Urological Nursing
- Keywords
- Anxiety, Confort, Cystoscopy, Heat Application, Pain, Bladder Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Emine KarakayaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 21 Nov 2024 (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.
This randomized controlled study was planned to determine the effect of hot application, which is one of the non-pharmacological methods that can be applied to reduce pain during the Rigid Cystoscopy procedure, on pain, anxiety and comfort levels on 62 persons.As a result, it was found that there was a statistically significant difference between the visual comparison scale scores during and after the procedure according to the participants' groups.
Detailed description
This study was planned to determine the effect of hot application, which is one of the non-pharmacological methods that can be applied to reduce pain during the Rigid Cystoscopy procedure, on pain, anxiety and comfort levels.
This study is a randomized controlled experimental study to determine the effect of heat application on patients' pain, anxiety and comfort levels during the cystoscopy procedure. The population of the research consisted of individuals who were hospitalized in the Cystoscopy unit of Manisa Provincial Health Directorate Merkez Efendi State Hospital between November 2023 - June 2024, and the sample consisted of individuals who met the inclusion criteriaan dagreed to participate in the research. Participants (n=62) were randomized into two groups: intervention (n=31) and control group (n=31) in a 1:1 ratio, using random numbers generated by the simple randomization method on the computer. The intervention group consisted of 5 women and 26 men, the control group consisted of 8 women and 23 men, a total of 13 women and 49 men who is over over 18 years The sample group was presented according to the CONSORT diagram. Heat application was not applied routinely to the intervention group, and unlike the intervention group, heat application was not applied only with thermophor to the control group. However, the scales and forms were evaluated and blood pressure and pulse rate were measured during the same period. Incollecting data; 'Individual Introduction Form', 'Information Form Regarding the Cystoscopy Procedure', 'Visual Comparison Scale (VAS)', 'Data Recording Form', 'State Anxiety Scale' and 'General Comfort Scale Short Form' were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomize two grup intervention and control grup
| Arm | Type | Receives |
|---|---|---|
| İntervention Group | Experimental | Other: Heat pedExperimental : Heat application was not applied routinely to the intervention group, and unlike the intervention group, heat application was not applied only with thermophor to the control group. However, the scales and forms were evaluated and blood pressure and pulse rate were measured during the same period. Incollecting data; 'Individual Introduction Form', 'Information Form Regarding the Cystoscopy Procedure', 'Visual Comparison Scale (VAS)', 'Data Recording Form', 'State Anxiety Scale' and 'General Comfort Scale Short Form' were used. Thermophor Prosedure Before the cystoscopy procedure, the temperature of the water was measured as 40-45°C. Approximately two-thirds of the bag was filled with hot water and the air in the bag was removed. The bag was dried and checked for leakage, then wrapped with the bag's cover and placed on the patient's lower abdomen body area 5 minutes before the cystoscopy procedure. |
| Control Group | No intervention | –The scales and forms were evaluated and blood pressure and pulse rate were measured during the same period. Incollecting data; 'Individual Introduction Form', 'Information Form Regarding the Cystoscopy Procedure', 'Visual Comparison Scale (VAS)', 'Data Recording Form', 'State Anxiety Scale' and 'General Comfort Scale Short Form' were used. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Rigid (rigid) cystoscopy was performed for diagnosis and / or treatment purposes (bladder tumor).
- Does not require anesthesia. Over 18 years old No communication barrier without severe disease Cystoscopy for the first time or for control purposes İndividuals who participated in this research for the first time and agreed to participate in the research constituted the inclusion criteria.
Key exclusion criteria (1 listed)
- Urinary hematuria. Urinary tract infection Overactive bladder Pelvic pain etc. A mental health disease, who had communication problems. Under 18 years of age. Anesthesia, Not agree to participate in the research were excluded from the study.
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 |
|---|---|---|
| Heat pedThe hot ped was used during ricig cystoscopy | Other | İntervention Group |
Primary outcome
Pain due to rigid cystoscopy
Time frame: 20 minutes
Vusiel analog scale was used(VAS, 0(good) - 10cm (worse)
Anxiety due to rigid cystoscopy
Time frame: 5 minutes
The state anxiety scale scores .The highest score is 80 (worse) and the lowest score is 20(good).
Confort levels due to rigid cystoscopy
Time frame: 5 minutes
General Comfort Scale Short Form (28(worse) -168(good)
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 21 Nov 2024.
- Background: PubMed 26984467Seklehner S, Engelhardt PF, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Wehrberger C, Librenjak D, Hubner W, Breinl E, Riedl C. Anxiety and depression analyses of patients undergoing diagnostic cystoscopy. Qual Life Res. 2016 Sep;25(9):2307-14. doi: 10.1007/s11136-016-1264-z. Epub 2016 Mar 17.
- Background: PubMed 29520385Kim SB, Yoon SG, Tae J, Kim JY, Shim JS, Kang SG, Cheon J, Lee JG, Kim JJ, Kang SH. Detection and recurrence rate of transurethral resection of bladder tumors by narrow-band imaging: Prospective, randomized comparison with white light cystoscopy. Investig Clin Urol. 2018 Mar;59(2):98-105. doi: 10.4111/icu.2018.59.2.98. Epub 2018 Feb 8.
- Background: PubMed 35196580Kwon OS, Kwon B, Kim J, Kim BH. Effects of Heating Therapy on Pain, Anxiety, Physiologic Measures, and Satisfaction in Patients Undergoing Cystoscopy. Asian Nurs Res (Korean Soc Nurs Sci). 2022 May;16(2):73-79. doi: 10.1016/j.anr.2022.02.002. Epub 2022 Feb 20.
- Results publication: PubMed 28097268Casteleijn NF, Vriesema JL, Stomps SP, van Balen OL, Cornel EB. The effect of office based flexible and rigid cystoscopy on pain experience in female patients. Investig Clin Urol. 2017 Jan;58(1):48-53. doi: 10.4111/icu.2017.58.1.48. Epub 2017 Jan 4.
- Individual participant dataSharing planned: No. The data will be given if it's necessary it is not problem for ethical office
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Anxiety, Biopsy
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.
Kıvan Çevik Kaya principal investigator
Manisa Celal Bayar Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat ped in people with Urological Nursing, run by Emine Karakaya 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 2 inclusion and 1 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 21 Nov 2024. 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?
Pain due to rigid cystoscopy (time frame: 20 minutes). The study lists 3 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 NCT06699173, which also lists 4 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 21 Nov 2024.