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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04466319
Other study ID # 80558721-050.99-E.25047
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2019
Est. completion date June 1, 2020

Study information

Verified date July 2020
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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".


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 1, 2020
Est. primary completion date July 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Rocking Chair
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.

Locations

Country Name City State
Turkey Dean of the Faculty of Medicine Ground Floor Meselik Campus Eskisehir Odunpazari

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary time to report of first flatus Defined as the first time flatus happens Defined as the first time hear the bowel sound after surgery1-5 days
Primary time to report of first defecation Defined as the first time defecation happens. End of surgery to the first defecation 1-7 days
Secondary length of postoperative hospitalization Defined as the length hospitalization after surgery End of surgery to hospital discharge 5-7 days
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