- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05057585
The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients Undergoing Major Surgery
The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
Major surgery are operations that can cause morbidity and mortality. Worldwide, approximately 230 million major surgical interventions are performed each year. Major surgery is a stressful experience and causes life-threatening fear and anxiety by increasing the level of anxiety. The most important of these fears is the pain that may occur after surgery. More than 75% of patients who experience postoperative pain in the Western world report that they experience moderate to severe pain. In our country, this rate is over 90%. If pain management is inadequate, patients' quality of life is adversely affected. In pain management, nurses can use non-pharmacological methods such as massage and exercise in addition to pharmacological applications.
Leg-arm exercises done in bed are aimed at protecting the muscle strength of individuals. Turning in bed, leg-arm exercises, raising the heels and feet, inverting the arms, moving from right to left, reverse arm and leg movements are performed. Also 6-8. Early ambulation is recommended. If these applications are made, early recovery and rapid discharge can be achieved. Since pain and anxiety delay early recovery in patients undergoing major surgery, effective pain management is very important. In this study, we aimed to examine the effects of in-bed exercises on anxiety and pain in patients undergoing major surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Malatya, Turkey
- Turgut Ozal Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older,
- Ability to communicate verbally and not having a cognitive problem,
- Defining pain severity of 4 and above,
- Willing to participate in the study,
- Having undergone major surgery.
Exclusion Criteria:
- The absence of open wounds and cellulite in the area to be applied,
- The absence of thrombophlebitis,
- The absence of deep vein thrombosis,
- The absence of inflammatory diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Exercise group
Each patient in the experimental group was given in-bed exercises for 15 minutes.
An anxiety questionnaire was asked to both the experimental and control groups.
It was expected that both the experimental and control group patients would be stable in the postoperative period.
The same exercises were applied again for 15 minutes to the patients who were stable after the surgery.
Then the patients were made to take steps around the bed.
Pain levels were measured.
|
Exercises (arm and leg exercises, turning in bed) were applied only to the experimental group.
It was applied for 15 minutes 12-24 hours before the operation.
|
|
NO_INTERVENTION: No treatment group
Apart from clinical protocols, no application was made in patient follow-up.
Anxiety scale was filled and pain level was evaluated.
Pain and anxiety scales were refilled within the same period without any application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: 0-15 minutes
|
It is the form in which the patient's anxiety is measured.
The expected value in the scale is between 0 and 50 points.
As the Scale Score increases, the level of anxiety also increases.
|
0-15 minutes
|
|
Pain level
Time Frame: 0-15 minutes
|
It is a measure of pain level.
Pain intensity ranges from 0 to 10, 0 points no pain, 10 points unbearable pain.
|
0-15 minutes
|
|
Early Ambulation
Time Frame: 0-15 minutes
|
It is the form in which the postoperative mobilization times are measured.
|
0-15 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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