Abdominal SurgeryNCT04730141
Effect of Mobilization Protocol on Mobilization
A study testing Patient mobilization with pre-operative mobilization training and mobilization protocol in people with Abdominal Surgery and Nursing, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of early mobilization protocol on patients' mobilization status and patient care outcomes in patients who undergo major abdominal surgery. This study is a prospective non-randomized controlled clinical trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Surgery, Nursing
- What is being tested?
- Patient mobilization with pre-operative mobilization training and mobilization protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2019to 27 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To undergo major abdominal open surgery
- ASA <IV
- Being over the age of 18
- Not having a barrier to communication
- Having agreed to participate in the study
Who cannot join
- Being diagnosed that may limit mobilization
- Being diagnosed with chronic obstructive pulmonary disease
- ASA IV-V-VI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mobilization Protocol on Mobilization Start Time and Patient Care Results in Patients Undergoing Abdominal Surgery
The aim of this study is to determine the effect of early mobilization protocol on patients' mobilization status and patient care outcomes in patients who undergo major abdominal surgery. This study is a prospective non-randomized controlled clinical trial.
Read the detailed description
The study sample consisted of 42 patients, 21 of whom were the control group and 21 were the intervention group, who had undergone major abdominal open surgery between May and September 2019. The routine mobilization follow-up approach of the intensive care unit was applied to the patients in the control group, and the early mobilization protocol developed by using up-to-date guidelines and expert opinions were applied to the patients in the intervention group. In the study, the data of the control group were firstly collected, then the early mobilization protocol was introduced to the patients through the training brochure prepared and then data of the intervention group were collected. In the study, the characteristics of the patients in both groups belonging to the preoperative period, the distance they walked in the 6-minute walking test and the results of the postoperative period were recorded.
- Conditions
- Abdominal Surgery, Nursing
- Being tested
- Patient mobilization with pre-operative mobilization training and mobilization protocol
- Keywords
- surgery and mobilization, early mobilization protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient mobilization with pre-operative mobilization training and mobilization protocolOther
Postoperative mobilization for the first 24 hours
| Study group | Role | What they receive |
|---|---|---|
| mobilization protocol | Experimental | The early mobilization protocol developed by using up-to-date guidelines and expert opinions were applied to the patients in the intervention group. Receives: Other: Patient mobilization with pre-operative mobilization training and mobilization protocol |
| routine care | No intervention | The routine mobilization follow-up approach of the intensive care unit was applied to the patients in the control group . |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of mobilization protocol on mobilization start time
In the postoperative period, the hour of mobilization of the patient was recorded.The group in which the mobilization protocol was applied and the group in which the mobilization protocol was not applied were compared
Measured: first 24 hours postoperatif
Postoperative sleep quality
VAS is considered a valid, reliable and usable measurement tool used to convert some values that cannot be measured numerically into numericals. Possible scores from 0 (worst case) to 10 (best case)
Measured: Postoperative 24th hour
Postoperative patient satisfaction
VAS is considered a valid, reliable and usable measurement tool used to convert some values that cannot be measured numerically into numericals. Possible scores from 0 (worst case) to 10 (best case)
Measured: Postoperative 24th hour
Secondary outcomes (1)
Postoperative number of steps
Pedometer programs are easy-to-use mobile applications where features such as the number of steps taken at a given time and walking distance can be recorded. Pedometer application is downloaded to the phone, the number of steps and walking distance are recorded by carrying it in a pocket or bag. In this study, Developer: ITO Technologies Inc, category: health and fitness, version 1.1.10 pedometer program was used.
Measured: The total number of steps taken during the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start29 May 2019
- Primary completion3 Sep 2019
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadime Koyuncu, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Emine Iyiun, Study director, Gulhane Hemsirelik Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730141
- Sponsor's protocol ID
- 19208
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 29 Jan 2021
- 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 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobilization Protocol on Mobilization Start Time and Patient Care Results in Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04730141
- Acronym / sponsor ID
- 19208
- Conditions
- Abdominal Surgery, Nursing
- Keywords
- surgery and mobilization, early mobilization protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 29 Jan 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.
The aim of this study is to determine the effect of early mobilization protocol on patients' mobilization status and patient care outcomes in patients who undergo major abdominal surgery. This study is a prospective non-randomized controlled clinical trial.
Detailed description
The study sample consisted of 42 patients, 21 of whom were the control group and 21 were the intervention group, who had undergone major abdominal open surgery between May and September 2019. The routine mobilization follow-up approach of the intensive care unit was applied to the patients in the control group, and the early mobilization protocol developed by using up-to-date guidelines and expert opinions were applied to the patients in the intervention group. In the study, the data of the control group were firstly collected, then the early mobilization protocol was introduced to the patients through the training brochure prepared and then data of the intervention group were collected. In the study, the characteristics of the patients in both groups belonging to the preoperative period, the distance they walked in the 6-minute walking test and the results of the postoperative period were recorded.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| mobilization protocol | Experimental | Other: Patient mobilization with pre-operative mobilization training and mobilization protocolThe early mobilization protocol developed by using up-to-date guidelines and expert opinions were applied to the patients in the intervention group. |
| routine care | No intervention | –The routine mobilization follow-up approach of the intensive care unit was applied to the patients in the control group . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- To undergo major abdominal open surgery
- ASA <IV
- Being over the age of 18
- Not having a barrier to communication
- Having agreed to participate in the study
Key exclusion criteria (3 listed)
- Being diagnosed that may limit mobilization
- Being diagnosed with chronic obstructive pulmonary disease
- ASA IV-V-VI
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 |
|---|---|---|
| Patient mobilization with pre-operative mobilization training and mobilization protocolPostoperative mobilization for the first 24 hours | Other | mobilization protocol |
Primary outcome
The effect of mobilization protocol on mobilization start time
Time frame: first 24 hours postoperatif
In the postoperative period, the hour of mobilization of the patient was recorded.The group in which the mobilization protocol was applied and the group in which the mobilization protocol was not applied were compared
Postoperative sleep quality
Time frame: Postoperative 24th hour
VAS is considered a valid, reliable and usable measurement tool used to convert some values that cannot be measured numerically into numericals. Possible scores from 0 (worst case) to 10 (best case)
Postoperative patient satisfaction
Time frame: Postoperative 24th hour
VAS is considered a valid, reliable and usable measurement tool used to convert some values that cannot be measured numerically into numericals. Possible scores from 0 (worst case) to 10 (best case)
1 secondary outcome
Postoperative number of steps
Time frame: The total number of steps taken during the first 24 hours postoperatively
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 29 Jan 2021.
- 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.
Emine Iyiun study director
Gulhane Hemsirelik Fakultesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient mobilization with pre-operative mobilization training and mobilization protocol in people with Abdominal Surgery and Nursing, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 5 inclusion and 3 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 29 Jan 2021. 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 mobilization protocol on mobilization start time (time frame: first 24 hours postoperatif). The study lists 3 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 29 Jan 2021.