Spinal AnesthesiaNCT05580289
The Effect of Local Dry Heat Applıcatıon and Half Shower on The Development of Urinary Retentıon and Paın
A study testing half-shower and hot pack in people with Spinal Anesthesia and Nursing, run by Duzce University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia, Nursing, Bladder Retention
- What is being tested?
- half-shower and hot pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Aug 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce Univercity Medical Fauculty
Düzce, 81600
About this study
Official title: The Effect of Local Dry Heat Applıcatıon and Half Shower on The Development of Postoperative Urinary Retentıon and Paın ın Patıents Applıed With Spınal Anesthesıa
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.
Read the detailed 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.
- Conditions
- Spinal Anesthesia, Nursing, Bladder Retention, Dry Heat Application, Half Shower, Pain
- Being tested
- half-shower and hot pack
- Medical subject headings
- Urinary Retention, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
half-shower and hot packOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: half-shower and hot pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: 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.
- 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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Jul 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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
- randomised
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- esra yatkın, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580289
- Sponsor's protocol ID
- Duzce-atiye-02
- Status last verified
- Oct 2023
- First submitted
- 15 Sep 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Dry Heat Applıcatıon and Half Shower on The Development of Postoperative Urinary Retentıon and Paın ın Patıents Applıed With Spınal Anesthesıa
- ClinicalTrials.gov ID
- NCT05580289
- Acronym / sponsor ID
- Duzce-atiye-02
- Conditions
- Spinal Anesthesia, Nursing, Bladder Retention, Dry Heat Application, Half Shower, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 14 Oct 2022 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomised
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: half-shower and hot packWarm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| half-shower and hot packThe 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. | Other | detrimental group |
Primary outcome
bladder retention
Time frame: one day
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.
pain level
Time frame: one day
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.
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 10 Oct 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.
esra yatkın principal investigator
Duzce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing half-shower and hot pack in people with Spinal Anesthesia and Nursing, run by Duzce University 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 5 inclusion and 5 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 10 Oct 2023. 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?
bladder retention (time frame: one day). 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?
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 10 Oct 2023.