NCT05580289

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

September 15, 2022

Last Update Submit

October 6, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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. İt contains every step related to research intervention such as bladder examination times, pain levels, etc. 1. It will be decided that the patient can be mobilized after the surgery, and this process takes approximately 1 hour. 2. It will be checked whether bladder retention has developed before the application. 3. Hot application (20 minutes) and half shower (5 minutes) will be applied for a total of 25 minutes. 4. It will be checked whether bladder retention develops after the application. 5. Bladder palpation will be performed every hour until patients pass their first urination. This process will take approximately 6-8 hours.

    one day

  • 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. 1. It will be decided that the patient can be mobilized after the surgery, and this process takes approximately 1 hour. 2. It will be checked whether the pain has developed before the application. 3. Hot application (20 minutes) and half shower (5 minutes) will be applied for a total of 25 minutes. 4. It will be checked whether pain develops or pain level change after the application. 5. Pain level will be performed every hour until patients pass their first urination.

    one day

Study Arms (2)

control group

NO INTERVENTION

Routine care of the patient will be done and the level of pain will be determined with McGill pain scale questionnaire short form

detrimental group

EXPERIMENTAL

Warm half shower + dry hot application will be applied to the experimental group in the early postoperative period.mplementation Phase: After mobilizing the patients in the experimental group, who have regained their muscle strength and can be mobilized, their legs will be washed with 40-45oC warm tap water for 5 minutes (down from the hip level) until their legs are up to the femur acetabulum level, and then the patient will be taken to the bed for 20 minutes. Dry hot application will be done over the bladder. Palpation and bladder examination will be performed every hour to understand bladder filling in patients who will be expected to urinate within 6-8 hours after surgery.

Other: half-shower and hot pack

Interventions

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.

detrimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duzce Univercity Medical Fauculty

Düzce, 81600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary RetentionPain

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • esra yatkın

    Duzce University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomised
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

October 14, 2022

Study Start

July 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations