- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04466319
The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery
The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery
The research will be carried out as a randomized controlled experimental study in patients with open gastrointestinal tract surgery in order to evaluate the effect of rocking chair movement to be given in addition to standard care in the initiation of postoperative bowel functions (post-operative first time gas, first time defecation).Ethics committee and institution permissions and written consents of individuals were obtained prior to the study.The universe of the study was composed of patients with open gastrointestinal surgery lying in the general surgery service of a hospital in Eskisehir. With the error margin of 0.05, 90% test power, 30 people in intervention and control groups, 60 patients in total will be included in the research.Appointment of patients to intervention and control groups was done by stratification and block randomization method according to gastric and intestinal surgery.The draw method was used to assign stratified patients to blind technique intervention and control groups in order to avoid side-holding, and an equal number (blocking) patients were assigned to each group. The individuals in the intervention group in the rocking chair three times a day, 20 minutes, a total of 60 minutes after the first day after surgery. The individuals in the control group will sit in a standard chair in the same time as the intervention group in the non-rocking chair. The data will be collected using the "Descriptive characteristics determination form", "Intervention Group Intestinal Functions Evaluation Form" and "Control Group Intestinal Functions Evaluation Form".
Study Overview
Detailed Description
Inclusion Criteria
- Accepting to participate in the research
- Being 18 or over
- Having gastrointestinal surgery
- No communication problems
- No symptoms or disease (dizziness, Vertigo, Meniere.) That rocking chair movement will adversely affect the patient
- With or without a stoma in the postoperative period;
- Patients with ASA (American Society of Anesthesiology) classification I or II
Exclusion Criteria
- Not agreeing to participate in the research
- Being 18 or under
- Being a communication problem
- The symptoms or disease (dizziness, Vertigo, Meniere.) That the rocking chair movement will adversely affect the patient.
- Having a history of ileus after surgery
- Any complication after surgery
- With inflammatory and irritable bowel disease
- Using drugs that will affect intestinal motility before or after surgery.
- Surgical intervention is laparoscopic
- ASA classification is III, IV or V
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Odunpazarı
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Eskişehir, Odunpazarı, Turkey, 26040
- Dean of the Faculty of Medicine Ground Floor Meşelik Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Agree to participate in the research
- Being 18 or over
- Having gastrointestinal surgery
- No communication problems
- No symptoms or disease (dizziness, Vertigo, Meniere.) That rocking chair movement will adversely affect the patient With or without a stoma in the postoperative period;
- Patients with American Society of Anesthesiology (ASA) classification I or II
Exclusion Criteria:
- Not agreeing to participate in the research
- being 18 or under
- Being a communication problem
- The symptoms or disease (dizziness, Vertigo, Meniere.) That the rocking chair movement will adversely affect the patient.
- Having a history of ileus after surgery
- Any complication after surgery
- With inflammatory and irritable bowel disease
- Using drugs that will affect intestinal motility before or after surgery.
- Surgical intervention is laparoscopic
- ASA classification is III, IV or V
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: intervention arm
The individuals in the intervention group in the rocking chair three times a day, 20 minutes, a total of 60 minutes after the first day after surgery.They did this intervention until they first defecation .
|
Patients in the experimental group were sat rocking chair three times a day in a rocking wooden chair in addition to their postoperative routine care by their nurses.
After providing the rocking chair to the patients' room, the researcher gave the data collection form to be filled by the patient himself.
It was the researcher's supervision that the patient sat in the rocking chair for the first time.
The rocking chair movement continued to intervene until the patient released gas.
After emitting gas, he continued to swing in the rocking chair until he made his first stools.
The patient was visited every day until he was discharged.
No special clothing or materials were required for the patients to sit in the rocking chair.
|
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NO_INTERVENTION: Control arm
The individuals in the control group sat in a standard chair in the same time as the intervention group in the non-rocking chair.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to report of first flatus
Time Frame: Defined as the first time hear the bowel sound after surgery1-5 days
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Defined as the first time flatus happens
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Defined as the first time hear the bowel sound after surgery1-5 days
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time to report of first defecation
Time Frame: End of surgery to the first defecation 1-7 days
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Defined as the first time defecation happens.
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End of surgery to the first defecation 1-7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
length of postoperative hospitalization
Time Frame: End of surgery to hospital discharge 5-7 days
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Defined as the length hospitalization after surgery
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End of surgery to hospital discharge 5-7 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nedime Köşgeroğlu, Prof, T.C. İstanbul Rumeli University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80558721-050.99-E.25047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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