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The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients Undergoing Major Surgery

Primary Purpose

Surgery, Anxiety, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Turning in bed, arm and leg exercises
Sponsored by
Gurkan Kapikiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgery focused on measuring Anxiety, Early ambulation, Bed exercise, Major surgery, Mobilization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Turgut Ozal Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

No treatment group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Anxiety
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.
Pain level
It is a measure of pain level. Pain intensity ranges from 0 to 10, 0 points no pain, 10 points unbearable pain.
Early Ambulation
It is the form in which the postoperative mobilization times are measured.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2021
Last Updated
March 16, 2022
Sponsor
Gurkan Kapikiran
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1. Study Identification

Unique Protocol Identification Number
NCT05057585
Brief Title
The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients Undergoing Major Surgery
Official Title
The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
April 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gurkan Kapikiran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the effects of bed exercises on pain, anxiety, early ambulation and mobilization in major surgery patients were aimed. The research was experimental and a total of 120 patients participated. Data were collected using an information form, anxiety scale, and pain scale. Exercise was applied to the patients in the experimental group (15 minutes) and no intervention was applied to the control group. Descriptive statistics, correlation tests and t-test were used. Cronbach's alpha coefficients were checked for the scales.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Anxiety, Pain
Keywords
Anxiety, Early ambulation, Bed exercise, Major surgery, Mobilization

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This research was conducted as a prospective and experimental study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Turning in bed, arm and leg exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
0-15 minutes
Title
Pain level
Description
It is a measure of pain level. Pain intensity ranges from 0 to 10, 0 points no pain, 10 points unbearable pain.
Time Frame
0-15 minutes
Title
Early Ambulation
Description
It is the form in which the postoperative mobilization times are measured.
Time Frame
0-15 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Turgut Ozal Medical Center
City
Malatya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients Undergoing Major Surgery

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