Effect of Heat Aplication to Patients During Cystoscopy Procedure

NCT ID: NCT06699173

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Urological Nursing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

randomize two grup intervention and control grup
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

İntervention Group

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.

Group Type EXPERIMENTAL

Heat ped

Intervention Type OTHER

The hot ped was used during ricig cystoscopy

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Heat ped

The hot ped was used during ricig cystoscopy

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Rigid (rigid) cystoscopy was performed for diagnosis and / or treatment purposes (bladder tumor).

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Emine Karakaya

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emine Karakaya

Nurse

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kıvan Çevik Kaya

Role: PRINCIPAL_INVESTIGATOR

Manisa Celal Bayar Üniversity

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Celal Bayar Üniversity

Manisa, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26984467 (View on PubMed)

Kim 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.

Reference Type BACKGROUND
PMID: 29520385 (View on PubMed)

Kwon 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.

Reference Type BACKGROUND
PMID: 35196580 (View on PubMed)

Casteleijn 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.

Reference Type RESULT
PMID: 28097268 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

221346001,CelalBayarU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.