Patient EngagementNCT04837378
The Effect of Abdominal Massage and In-bed Exercise on Enteral Nutrition
A study testing Abdominal Massage and In-bed Exercise in people with Patient Engagement, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Enteral nutrition is often preferred in intensive care units, but it brings some potential complications in addition to its benefits. It is stated that abdominal massage and in-bed exercise in intensive care patients can reduce complications related to the gastrointestinal system when performed under appropriate… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patient Engagement
- What is being tested?
- Abdominal Massage and In-bed Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 31 Aug 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients connected to a mechanical ventilator
- Patients who started enteral feeding with a nasogastric tube at least 24 hours ago
- Patients with no injuries to the extremity and abdominal area
- Patients without intestinal obstruction
- Patients who have not received abdominal radiotherapy and have not undergone abdominal surgery during the last six weeks
- Patients with Glasgow Coma Score (GCS) > 3
- Patients with Acute Physiology and Chronic Health Evaluation (APACHE II)> 16
- Patients given consent by their first-degree relative
Who cannot join
- • Patients whose enteral feeding was discontinued during the study
- Patients who show signs of infection due to VAP or other infections during or before the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Gazi Yaşargil Training and Research Hospital
Diyarbakır, 21070
About this study
Official title: Effects of Abdominal Massage and In-Bed Exercise on Gastrointestinal Complications and Patient Comfort in Intensive Care Patients Eating Enterally
Enteral nutrition is often preferred in intensive care units, but it brings some potential complications in addition to its benefits. It is stated that abdominal massage and in-bed exercise in intensive care patients can reduce complications related to the gastrointestinal system when performed under appropriate conditions. Considering the ease of application, low cost and non-invasive nature of abdominal massage and in-bed exercises, it is predicted that patients will benefit in case of gastrointestinal complications and positive effects on comfort. It is also thought that these interventions that support independent nursing roles will contribute to the establishment of standards of care and the professionalization process by using evidence-based practices.
This study is conducted to evaluate the effects of abdominal massage and in-bed exercise on gastrointestinal complications and patient comfort in intensive care patients who are fed enterally.
Read the detailed description
Enteral nutrition is often preferred in intensive care units, but it brings some potential complications in addition to its benefits. It is stated that abdominal massage and in-bed exercise in intensive care patients can reduce complications related to the gastrointestinal system when performed under appropriate conditions. Considering the ease of application, low cost and non-invasive nature of abdominal massage and in-bed exercises, it is predicted that patients will benefit in case of gastrointestinal complications and positive effects on comfort. It is also thought that these interventions that support independent nursing roles will contribute to the establishment of standards of care and the professionalization process by using evidence-based practices.
This study is conducted to evaluate the effects of abdominal massage and in-bed exercise on gastrointestinal complications and patient comfort in intensive care patients who are fed enterally.
The research is planned to be completed between April 15, 2021 and July 15, 2022. The universe of the study, which was conducted as a randomized controlled study model, consisted of patients with intubated enteral nutrition in the internal intensive care units of Diyarbakır Gazi Yaşargil Training and Research Hospital and Dicle University Medical Faculty. Participants were planned to be assigned to the experimental and control groups by stratification and block randomization (Abdominal massage group = 46 participant, in-bed exercise group = 46 participant and control group = 46 participant). Demographic Characteristics Form, Enteral Nutrition Follow-up Form, Richmond Agitation-Sedation Scale, Intensive Care Pain Observation Scale and Comfort Behavior Checklist were used to collect data. According to the characteristics of the data, t test, ANOVA test, Mann Whitney U test and correlation were measured in independent groups.
- Conditions
- Patient Engagement
- Being tested
- Abdominal Massage, In-bed Exercise
- Keywords
- Abdominal Massage, Enteral Nutrition, Comfort, In-Bed Exercise, Intensive Care
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal MassageOther
The massage starts from the left lower quadrant of the sigmoid colon. After the initial tension is removed, deep effloration, petrization and vibration maneuvers are started. Finally, the process is completed in about 15 minutes to cover the entire column.
In-bed ExerciseOther
In-bed exercises are passive exercises performed by caregivers when the patient is dependent on the bed, that is, when he cannot actively move on his own. These are movements applied to all joints of the upper and lower extremities and in all directions. Exercises are done in all directions on finger joints of both hands, wrists, elbow and shoulder joints, finger joints of both feet, ankles, knee and hip joints.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage Group | Experimental | Abdominal massage process stage; After the preliminary test data were obtained, the hands were warmed and creamed with vaseline, abdominal massage was applied to the patient in the supine position for 15 minutes. After 24 hours, gastrointestinal complications and comfort parameters were recorded. Receives: Other: Abdominal Massage |
| In-bed Exercise Group | Experimental | In-bed exercise process phase; After the pre-test data were obtained, the patient was applied passive in-bed exercises for approximately 15 minutes in all extremities in the supine position. After 24 hours, gastrointestinal complications and comfort parameters were recorded. Receives: Other: In-bed Exercise |
| Control Group | No intervention | Control group stage; Gastrointestinal complications and comfort parameters were recorded in this group at the same time as the experimental groups without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of abdominal massage on gastrointestinal complications
Abdominal massage was repeated for 3 days, and gastric residual volume, defecation frequency, vomiting number, abdominal distension, constipation and diarrhea status and blood glucose measurement were recorded before each abdominal massage.
Measured: About 6 months
The effect of abdominal massage on patient comfort
Comfort behavior checklist (CBC) consists of 30 behavioral indicators, pain and comfort scores. Minimum score is 25, maximum score is 100. High scores indicate a high level of comfort. Scoring was done before and after abdominal massage.
Measured: About 6 months
Effects of in-bed exercise on gastrointestinal complications
The in-bed exercise was repeated for 3 days and the gastric residual volume, defecation frequency, vomiting number, abdominal distension, constipation and diarrhea status, and blood glucose measurement were recorded in the enteral nutrition follow-up form before each exercise.
Measured: About 6 months
The effect of in-bed exercise on patient comfort
The comfort behavior checklist (CBC) consists of 30 behavioral indicators, pain and comfort scores. Minimum score is 25, maximum score is 100. High scores indicate a high level of comfort. Scoring was done before and after the in-bed exercise.
Measured: About 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Apr 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, patients will be stratified according to their gender (male and female) status and the blocking process will be performed. 46 patients will be included in each group by repeating the layers formed according to the specified variables 3 times. The stratified patients will be assigned to the experimental and control groups, and the research groups will be written on papers for the determined sets and a lot will be drawn. Group 1: Abdominal Massage 2. Group: In-bed Exercise 3. Group: Control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha CENGİZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837378
- Sponsor's protocol ID
- 2021/1839
- Status last verified
- Nov 2023
- First submitted
- 2 Apr 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research is a doctoral thesis study. The research is expected to be completed.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Massage and In-Bed Exercise on Gastrointestinal Complications and Patient Comfort in Intensive Care Patients Eating Enterally
- ClinicalTrials.gov ID
- NCT04837378
- Acronym / sponsor ID
- 2021/1839
- Conditions
- Patient Engagement
- Keywords
- Abdominal Massage, Enteral Nutrition, Comfort, In-Bed Exercise, Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 8 Apr 2021 (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.
Enteral nutrition is often preferred in intensive care units, but it brings some potential complications in addition to its benefits. It is stated that abdominal massage and in-bed exercise in intensive care patients can reduce complications related to the gastrointestinal system when performed under appropriate conditions. Considering the ease of application, low cost and non-invasive nature of abdominal massage and in-bed exercises, it is predicted that patients will benefit in case of gastrointestinal complications and positive effects on comfort. It is also thought that these interventions that support independent nursing roles will contribute to the establishment of standards of care and the professionalization process by using evidence-based practices.
This study is conducted to evaluate the effects of abdominal massage and in-bed exercise on gastrointestinal complications and patient comfort in intensive care patients who are fed enterally.
Detailed description
Enteral nutrition is often preferred in intensive care units, but it brings some potential complications in addition to its benefits. It is stated that abdominal massage and in-bed exercise in intensive care patients can reduce complications related to the gastrointestinal system when performed under appropriate conditions. Considering the ease of application, low cost and non-invasive nature of abdominal massage and in-bed exercises, it is predicted that patients will benefit in case of gastrointestinal complications and positive effects on comfort. It is also thought that these interventions that support independent nursing roles will contribute to the establishment of standards of care and the professionalization process by using evidence-based practices.
This study is conducted to evaluate the effects of abdominal massage and in-bed exercise on gastrointestinal complications and patient comfort in intensive care patients who are fed enterally.
The research is planned to be completed between April 15, 2021 and July 15, 2022. The universe of the study, which was conducted as a randomized controlled study model, consisted of patients with intubated enteral nutrition in the internal intensive care units of Diyarbakır Gazi Yaşargil Training and Research Hospital and Dicle University Medical Faculty. Participants were planned to be assigned to the experimental and control groups by stratification and block randomization (Abdominal massage group = 46 participant, in-bed exercise group = 46 participant and control group = 46 participant). Demographic Characteristics Form, Enteral Nutrition Follow-up Form, Richmond Agitation-Sedation Scale, Intensive Care Pain Observation Scale and Comfort Behavior Checklist were used to collect data. According to the characteristics of the data, t test, ANOVA test, Mann Whitney U test and correlation were measured in independent groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- In the study, patients will be stratified according to their gender (male and female) status and the blocking process will be performed. 46 patients will be included in each group by repeating the layers formed according to the specified variables 3 times. The stratified patients will be assigned to the experimental and control groups, and the research groups will be written on papers for the determined sets and a lot will be drawn. Group 1: Abdominal Massage 2. Group: In-bed Exercise 3. Group: Control
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage Group | Experimental | Other: Abdominal MassageAbdominal massage process stage; After the preliminary test data were obtained, the hands were warmed and creamed with vaseline, abdominal massage was applied to the patient in the supine position for 15 minutes. After 24 hours, gastrointestinal complications and comfort parameters were recorded. |
| In-bed Exercise Group | Experimental | Other: In-bed ExerciseIn-bed exercise process phase; After the pre-test data were obtained, the patient was applied passive in-bed exercises for approximately 15 minutes in all extremities in the supine position. After 24 hours, gastrointestinal complications and comfort parameters were recorded. |
| Control Group | No intervention | –Control group stage; Gastrointestinal complications and comfort parameters were recorded in this group at the same time as the experimental groups without any intervention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Patients connected to a mechanical ventilator
Key exclusion criteria (2 listed)
- • Patients whose enteral feeding was discontinued during the study
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 |
|---|---|---|
| Abdominal MassageThe massage starts from the left lower quadrant of the sigmoid colon. After the initial tension is removed, deep effloration, petrization and vibration maneuvers are started. Finally, the process is completed in about 15 minutes to cover the entire column. | Other | Abdominal Massage Group |
| In-bed ExerciseIn-bed exercises are passive exercises performed by caregivers when the patient is dependent on the bed, that is, when he cannot actively move on his own. These are movements applied to all joints of the upper and lower extremities and in all directions. Exercises are done in all directions on finger joints of both hands, wrists, elbow and shoulder joints, finger joints of both feet, ankles, knee and hip joints. | Other | In-bed Exercise Group |
Primary outcome
The effect of abdominal massage on gastrointestinal complications
Time frame: About 6 months
Abdominal massage was repeated for 3 days, and gastric residual volume, defecation frequency, vomiting number, abdominal distension, constipation and diarrhea status and blood glucose measurement were recorded before each abdominal massage.
The effect of abdominal massage on patient comfort
Time frame: About 6 months
Comfort behavior checklist (CBC) consists of 30 behavioral indicators, pain and comfort scores. Minimum score is 25, maximum score is 100. High scores indicate a high level of comfort. Scoring was done before and after abdominal massage.
Effects of in-bed exercise on gastrointestinal complications
Time frame: About 6 months
The in-bed exercise was repeated for 3 days and the gastric residual volume, defecation frequency, vomiting number, abdominal distension, constipation and diarrhea status, and blood glucose measurement were recorded in the enteral nutrition follow-up form before each exercise.
The effect of in-bed exercise on patient comfort
Time frame: About 6 months
The comfort behavior checklist (CBC) consists of 30 behavioral indicators, pain and comfort scores. Minimum score is 25, maximum score is 100. High scores indicate a high level of comfort. Scoring was done before and after the in-bed exercise.
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 14 Nov 2023.
- Individual participant dataSharing planned: No. This research is a doctoral thesis study. The research is expected to be completed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Massage and In-bed Exercise in people with Patient Engagement, run by Inonu 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 8 inclusion and 2 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 14 Nov 2023. 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?
The effect of abdominal massage on gastrointestinal complications (time frame: About 6 months). The study lists 4 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 14 Nov 2023.