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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05580289
Other study ID # Duzce-atiye-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date August 1, 2023

Study information

Verified date October 2023
Source Duzce University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Urinary retention is defined as the inability to empty the bladder spontaneously even though the bladder is full. Although urinary retention is seen in two forms as acute and chronic, acute urinary retention is defined by the International Continence Society (ICS) as the situation where the patient is unable to urinate, the bladder is felt when palpated by hand, and the bladder content contains at least 150 ml of urine with pain. Chronic bladder retention is defined by ICS as a painless condition that can be felt when the bladder is palpated manually after urinating, with at least 150 ml of urine in the bladder content. aim:The aim of this study is to determine the Effect of Postoperative Local Dry Hot Application and Half Shower Application on the Development of Bladder Retention and Pain in Patients undergoing Spinal Anesthesia.


Description:

Urinary retention is defined as the inability to empty the bladder spontaneously even though the bladder is full. Although urinary retention is seen in two forms as acute and chronic, acute urinary retention is defined by the International Continence Society (ICS) as the situation where the patient is unable to urinate, the bladder is felt when palpated by hand, and the bladder content contains at least 150 ml of urine with pain. Chronic bladder retention is defined by ICS as a painless condition that can be felt when the bladder is palpated manually after urinating, with at least 150 ml of urine in the bladder content. aim:The aim of this study is to determine the Effect of Postoperative Local Dry Hot Application and Half Shower Application on the Development of Bladder Retention and Pain in Patients undergoing Spinal Anesthesia. methot : The study was planned as a single-blind randomized controlled experimental study with a parallel group design. In the study, half shower and dry hot application will be applied to the patients in the experimental group. On the other hand, the control group patients will not receive any intervention other than general treatment and care. Dry hot application and half shower application method used in the study is a method used routinely in nursing care. In this study, the effectiveness of this method, which is used routinely, will be tried to be demonstrated. Randomization will be done by block randomization method. Patients meeting the inclusion criteria will be assigned to the groups after obtaining their informed consent to accept the study. Assignment to groups will be made at randomizer.org. In the analysis made in the G* power 3.1.9.7 program, it was determined that a total of 60 people should be reached. After the calculated sample size, 20% more of the sample will be included in the study in order to avoid the attrition bias. Therefore, it is aimed to complete the study with 72 patients. There will be two groups as control and experimental groups in the research. Warm half shower + dry hot application will be applied to the experimental group in the early postoperative period, and the other group will be the control group, whose routine care will be performed.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Receiving spinal anesthesia - Be over 18 years old - Mobilize - Agreeing to participate in the study voluntarily. - To speak Turkish and to be able to read and write Exclusion Criteria: - Having any kidney disease - Having a urological problem involving the bladder and urethra - Not being able to mobilize - Not being willing to participate in the study - Presence of incision in the suprapubic region

Study Design


Intervention

Other:
half-shower and hot pack
The patients in the experimental group will be given hot application and half shower applications and the pain levels of the patients and the development of bladder retention will be followed.

Locations

Country Name City State
Turkey Duzce Univercity Medical Fauculty Duzce

Sponsors (1)

Lead Sponsor Collaborator
Duzce University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary bladder retention The risk of developing bladder retention after surgery is expected to decrease in the experimental group compared to the post-intervention control group.
We will use an implementation checking form that researchers prepare. It contains every step related to research intervention such as bladder examination times, pain levels, etc.
It will be decided that the patient can be mobilized after the surgery, and this process takes approximately 1 hour.
It will be checked whether bladder retention has developed before the application.
Hot application (20 minutes) and half shower (5 minutes) will be applied for a total of 25 minutes.
It will be checked whether bladder retention develops after the application.
Bladder palpation will be performed every hour until patients pass their first urination.
This process will take approximately 6-8 hours.
one day
Primary pain level Pain is expected to decrease in the experimental group compared to the control group after half-shower and hot application.
Pain measurement will be made by McGill Pain Survey Short Form. The survey includes a visual analog score. The intensity of pain will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain I felt in my life).
The risk of developing pain after surgery is expected to change in the experimental group compared to the post-intervention control group.
It will be decided that the patient can be mobilized after the surgery, and this process takes approximately 1 hour.
It will be checked whether the pain has developed before the application.
Hot application (20 minutes) and half shower (5 minutes) will be applied for a total of 25 minutes.
It will be checked whether pain develops or pain level change after the application.
Pain level will be performed every hour until patients pass their first urination.
one day
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