NCT04466319

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".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

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

Study Start

First participant enrolled

March 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 1, 2020

Last Update Submit

July 7, 2020

Conditions

Keywords

IleusGastrointestinal DiseasesGastrointestinal MotilityPostoperative ComplicationsNurses

Outcome Measures

Primary Outcomes (2)

  • 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

  • time to report of first defecation

    Defined as the first time defecation happens.

    End of surgery to the first defecation 1-7 days

Secondary Outcomes (1)

  • length of postoperative hospitalization

    End of surgery to hospital discharge 5-7 days

Study Arms (2)

intervention arm

EXPERIMENTAL

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 .

Other: Rocking Chair

Control arm

NO INTERVENTION

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

Interventions

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.

intervention arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dean of the Faculty of Medicine Ground Floor Meşelik Campus

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

IleusGastrointestinal DiseasesPostoperative Complications

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nedime Köşgeroğlu, Prof

    T.C. İstanbul Rumeli University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 10, 2020

Study Start

March 15, 2019

Primary Completion

July 15, 2019

Study Completion

June 1, 2020

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations