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Abdominal SurgeryNCT05657561

The Effect of Early Mobilization Training on Mobility, Pain and Comfort After Abdominal Surgery

A study testing early mobilization in people with Abdominal Surgery, run by Eastern Mediterranean University at 2 sites in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of this study is to examine the effects of in-bed rotation and early mobilization training given before abdominal surgery on mobility, pain and comfort of patients after surgery. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Abdominal Surgery
What is being tested?
early mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
2 sitesCyprus
Study dates
2 Feb 2022to 31 Dec 2023
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 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • over 18 years old
  • those with abdominal surgery

Who cannot join

  • -

Trial locations and contacts

2 sites in 1 country.

Cyprus2 sites

  • Eastern Mediterranean University

    Famagusta, 99450

  • Eastern Mediterranean University

    Famagusta

Other trials in Cyprus

About this study

The primary aim of this study is to examine the effects of in-bed rotation and early mobilization training given before abdominal surgery on mobility, pain and comfort of patients after surgery. The secondary aim of the study is to examine the effect of mobilization training given before abdominal surgery on the sleep of patients after surgery.

Read the detailed description

The primary aim of this clinical trial study is to examine the effects of early mobilization training given before abdominal surgery on mobility, pain and comfort of patients after surgery. The secondary aim of the study is to examine the effect of mobilization training given before abdominal surgery on the sleep of patients after surgery. Research Hypotheses are:

H11. There is a difference between the mobility scores of the patients who were given and not given pre-abdominal surgery training.

H12. There is a difference between the comfort scores of patients who were given and not given pre-abdominal surgery training.

H13. There is a difference between the sleep scores of the patients who were given and not given pre-abdominal surgery training.

First, the patient's mobility status in the preoperative period was evaluated with these scales. "Early Mobilization Training" will be given to the patients in the intervention group in the preoperative period. "Early Mobilization Training Material" to be prepared by the researcher will be used as training material. The training content will include information about the techniques and points to be considered about turning from one side to the other in the bed, sitting on the side of the bed, standing on the side of the bed and walking in the patient's room, and the time spent outside the bed on the day of surgery and the first and subsequent days after surgery.

After the patient's mobilization on the first day after the operation, the Patient Mobility Scale, the Postoperative Mobilization, the Visual Analogue Scale (VAS) questions questioning the pain and comfort during lying and sitting, and sleep status will be filled.

Being tested
early mobilization
Keywords
abdominal surgery, early mobilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • early mobilizationOther

    Mobilization training was given to the intervention group.

Study groups in NCT05657561
Study groupRoleWhat they receive
early mobilizationExperimentalPatients in the intervention group will be given "Early Mobilization Training" in the preoperative preparation unit in the preoperative period.
Receives: Other: early mobilization
routine clinical careNo interventionPatients in the control group will receive routine clinical care .Routine post-operative mobilization procedure will be delivered by clinic doctors and nurses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Mobility Scale

    he level of pain and difficulty experienced during the 4 post-surgical activities (turning from one side of the bed to the other, sitting by the bed, standing up at the bedside, and walking in the patient's room) is evaluated using a 15 cm visual analog with verbal expressions listed at the bottom along the scale.

    The numerical value of the degree of pain and difficulty is determined by measuring the distance between the mark on the scale and "0" with a calibrated ruler. An increase in scores indicates an increase in pain and difficulty related to activity. The scores obtained give the patient's mobility score for each activity. The average score value is calculated. Scores for all activities are added together to obtain the global patient mobility score. The total score that can be obtained from the scale varies between 0-120.

    Measured: Change in Baseline Patient mobility score at two days

Secondary outcomes (2)

  1. pain level

    Preoperative and postoperative pain levels of the patients will be measured with the Visual Anolog Scale for pain.The Visual Analog Scale is a self-reported based measurement tool that is often used to measure subjective experiences pain. In this study, Visual Analog Scale for pain was used to make a numerical definition of a participant's pain levels with the participants' self-reports. Numbers between 0-10 were defined on a line, and the participants were asked to indicate the number of pain intensity levels they feel on this line. Participants with no pain scored 0 and extremely pain participants scored 10.

    Measured: Change in Baseline Patient pain score at two days

  2. comfort level in bed and while sitting

    The comfort level of the patients while turning and sitting in bed will be measured with the Visual Analog Scale for Comfort. In this study, Visual Analog Scale for comfort was used to make a numerical definition of a participant's comfort levels with the participants' self-reports. Numbers between 0-10 were defined on a line, and the participants were asked to indicate the number of comfort intensity levels they feel on this line. Participants with no comfort scored 0 and extremely comfort participants scored 10.

    Measured: Change in Baseline comfort score at two days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2022
  2. Study start2 Feb 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental study with pretest posttest control group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05657561
Sponsor's protocol ID
FD_01
Status last verified
Aug 2024
First submitted
27 Nov 2022
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • O'Shea G. Ventricular assist devices: what intensive care unit nurses need to know about postoperative management. AACN Adv Crit Care. 2012 Jan-Mar;23(1):69-83; quiz 84-5. doi: 10.1097/NCI.0b013e318240aaa9.

    PubMed 22290092

  • Auyong DB, Allen CJ, Pahang JA, Clabeaux JJ, MacDonald KM, Hanson NA. Reduced Length of Hospitalization in Primary Total Knee Arthroplasty Patients Using an Updated Enhanced Recovery After Orthopedic Surgery (ERAS) Pathway. J Arthroplasty. 2015 Oct;30(10):1705-9. doi: 10.1016/j.arth.2015.05.007. Epub 2015 May 12.

    PubMed 26024988

  • Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.

    PubMed 22807649

  • Castelino T, Fiore JF Jr, Niculiseanu P, Landry T, Augustin B, Feldman LS. The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review. Surgery. 2016 Apr;159(4):991-1003. doi: 10.1016/j.surg.2015.11.029. Epub 2016 Jan 21.

    PubMed 26804821

  • Chen LC, Wang TF, Shih YN, Wu LJ. Fifteen-minute music intervention reduces pre-radiotherapy anxiety in oncology patients. Eur J Oncol Nurs. 2013 Aug;17(4):436-41. doi: 10.1016/j.ejon.2012.11.002. Epub 2012 Dec 4.

    PubMed 23218591

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

    PubMed 26827847

  • Park DI, Kim HJ, Park JH, Cho YK, Sohn CI, Jeon WK, Kim BI, Ryu SH, Sung IK. Factors affecting abdominal pain during colonoscopy. Eur J Gastroenterol Hepatol. 2007 Aug;19(8):695-9. doi: 10.1097/01.meg.0000219097.32811.24.

    PubMed 17625440

  • Hashem MD, Nelliot A, Needham DM. Early Mobilization and Rehabilitation in the ICU: Moving Back to the Future. Respir Care. 2016 Jul;61(7):971-9. doi: 10.4187/respcare.04741. Epub 2016 Apr 19.

    PubMed 27094396

Questions about this trial

What is this clinical trial studying?

A study testing early mobilization in people with Abdominal Surgery, run by Eastern Mediterranean University at 2 sites in Cyprus.

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 2 inclusion and 1 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 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Cyprus. 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?

Patient Mobility Scale (time frame: Change in Baseline Patient mobility score at two days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05657561, which also lists 8 linked publications.

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 28 Aug 2024.

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