Postoperative IleusNCT04466319
The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery
A study testing Rocking Chair in people with Postoperative Ileus, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Rocking Chair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2019to 1 Jun 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dean of the Faculty of Medicine Ground Floor Meşelik Campus
Eskişehir, Odunpazarı, 26040
About this study
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".
Read the 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
- Conditions
- Postoperative Ileus
- Being tested
- Rocking Chair
- Keywords
- Ileus, Gastrointestinal Diseases, Gastrointestinal Motility, Postoperative Complications, Nurses
- Medical subject headings
- Ileus, Gastrointestinal Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocking ChairOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to report of first flatus
Defined as the first time flatus happens
Measured: 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.
Measured: End of surgery to the first defecation 1-7 days
Secondary outcomes (1)
length of postoperative hospitalization
Defined as the length hospitalization after surgery
Measured: End of surgery to hospital discharge 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 Mar 2019
- Primary completion15 Jul 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Şara, Eskisehir Osmangazi University
- Investigators
- Nedime Köşgeroğlu, Prof, Study director, T.C. İstanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466319
- Sponsor's protocol ID
- 80558721-050.99-E.25047
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 10 Jul 2020
- 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 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery
- ClinicalTrials.gov ID
- NCT04466319
- Acronym / sponsor ID
- 80558721-050.99-E.25047
- Conditions
- Postoperative Ileus
- Keywords
- Ileus, Gastrointestinal Diseases, Gastrointestinal Motility, Postoperative Complications, Nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 10 Jul 2020 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Other: Rocking ChairThe 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 . |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Rocking ChairPatients 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. | Other | intervention arm |
Primary outcome
time to report of first flatus
Time frame: Defined as the first time hear the bowel sound after surgery1-5 days
Defined as the first time flatus happens
time to report of first defecation
Time frame: End of surgery to the first defecation 1-7 days
Defined as the first time defecation happens.
1 secondary outcome
length of postoperative hospitalization
Time frame: End of surgery to hospital discharge 5-7 days
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 Jul 2020.
- 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.
Nedime Köşgeroğlu, Prof study director
T.C. İstanbul Rumeli 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 Rocking Chair in people with Postoperative Ileus, run by Eskisehir Osmangazi 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 6 inclusion and 10 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 Jul 2020. 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?
time to report of first flatus (time frame: Defined as the first time hear the bowel sound after surgery1-5 days). 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 Jul 2020.