NCT05961345

Brief Summary

According to the definition of the WHO, obesity is the abnormal or excessive accumulation of fat in the body. Laparoscopic operations; It is a popular choice for bariatric surgery. A study is planned to determine postoperative early mobilization, postoperative pain and hospital stay in patients hospitalized in Bariatric Surgery post-operative clinics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

July 18, 2023

Last Update Submit

December 8, 2024

Conditions

Keywords

ObesityMobilizationPainBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • The Numerical Pain Rating Acale (NRS)

    Numerical pain rating scale is a scale that evaluates the severity of pain from 0 to 10.As the severity of pain increases, the number value increases. A number value of 0 means no pain, while 10 is the most severe pain.

    72 hours

Study Arms (2)

early mobilization

EXPERIMENTAL

The patients in the experimental group were mobilized at the 4th postoperative hour.

Other: late mobilization

control group (late mobilization)

NO INTERVENTION

The patients in the control group were mobilized at the 6th hour as in the routine of the clinic.

Interventions

Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people.

Also known as: Early mobilization of patients after surgery is supported. The relationship between early mobilization and pain level was examined. The experimental group is 80 people.
early mobilization

Eligibility Criteria

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

You may qualify if:

  • Over 18 years old
  • Can speak Turkish
  • Agreeing to participate in the study
  • No postoperative complications
  • Patients with American Society of Anesthesiology (ASA) evaluation I, II, III were included in the sample group

You may not qualify if:

  • Can not speak Turkish
  • Refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, Yüreğir, 01220, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, MorbidObesityPain

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Officials

  • Cansel Bozer

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the experimental group was conducted early by the researcher and the outcome evaluations were performed by the researcher who blinded the group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups, a control and an experimental group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 27, 2023

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations