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The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery

Primary Purpose

Postoperative Ileus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rocking Chair
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Ileus focused on measuring Ileus, Gastrointestinal Diseases, Gastrointestinal Motility, Postoperative Complications, Nurses

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dean of the Faculty of Medicine Ground Floor Meşelik Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention arm

Control arm

Arm Description

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 .

The individuals in the control group sat in a standard chair in the same time as the intervention group in the non-rocking chair.

Outcomes

Primary Outcome Measures

time to report of first flatus
Defined as the first time flatus happens
time to report of first defecation
Defined as the first time defecation happens.

Secondary Outcome Measures

length of postoperative hospitalization
Defined as the length hospitalization after surgery

Full Information

First Posted
July 1, 2020
Last Updated
July 7, 2020
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04466319
Brief Title
The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery
Official Title
The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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".
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
Ileus, Gastrointestinal Diseases, Gastrointestinal Motility, Postoperative Complications, Nurses

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled experimental study in patients with open gastrointestinal tract surgery to evaluate the effect of rocking chair movement to be given in addition to standard care at the start of postoperative bowel functions (post-operative first gas, initial defecation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention arm
Arm Type
Experimental
Arm Description
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 .
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
The individuals in the control group sat in a standard chair in the same time as the intervention group in the non-rocking chair.
Intervention Type
Other
Intervention Name(s)
Rocking Chair
Intervention Description
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.
Primary Outcome Measure Information:
Title
time to report of first flatus
Description
Defined as the first time flatus happens
Time Frame
Defined as the first time hear the bowel sound after surgery1-5 days
Title
time to report of first defecation
Description
Defined as the first time defecation happens.
Time Frame
End of surgery to the first defecation 1-7 days
Secondary Outcome Measure Information:
Title
length of postoperative hospitalization
Description
Defined as the length hospitalization after surgery
Time Frame
End of surgery to hospital discharge 5-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nedime Köşgeroğlu, Prof
Organizational Affiliation
T.C. İstanbul Rumeli University
Official's Role
Study Director
Facility Information:
Facility Name
Dean of the Faculty of Medicine Ground Floor Meşelik Campus
City
Eskişehir
State/Province
Odunpazarı
ZIP/Postal Code
26040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery

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