NCT05657561

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

November 27, 2022

Last Update Submit

August 27, 2024

Conditions

Keywords

abdominal surgeryearly mobilization

Outcome Measures

Primary Outcomes (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.

    Change in Baseline Patient mobility score at two days

Secondary Outcomes (2)

  • pain level

    Change in Baseline Patient pain score at two days

  • comfort level in bed and while sitting

    Change in Baseline comfort score at two days

Study Arms (2)

early mobilization

EXPERIMENTAL

Patients in the intervention group will be given "Early Mobilization Training" in the preoperative preparation unit in the preoperative period.

Other: early mobilization

routine clinical care

NO INTERVENTION

Patients in the control group will receive routine clinical care .Routine post-operative mobilization procedure will be delivered by clinic doctors and nurses

Interventions

Mobilization training was given to the intervention group.

early mobilization

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years old
  • those with abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eastern Mediterranean University

Famagusta, 99450, Cyprus

Location

Eastern Mediterranean University

Famagusta, Cyprus

Location

Related Publications (8)

  • 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.

    PMID: 22290092BACKGROUND
  • 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.

    PMID: 26024988BACKGROUND
  • Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.

    PMID: 22807649BACKGROUND
  • 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.

    PMID: 26804821BACKGROUND
  • 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.

    PMID: 23218591BACKGROUND
  • 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.

    PMID: 26827847BACKGROUND
  • 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.

    PMID: 17625440BACKGROUND
  • 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.

    PMID: 27094396BACKGROUND

Related Links

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Sevinc Tastan, Prof.

    Eastern Mediterranean University, Health Sciences Faculty, Famagusta, North Cyprus,

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Patients who have had abdominal surgery
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Experimental study with pretest posttest control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 27, 2022

First Posted

December 20, 2022

Study Start

February 2, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations