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

NCT05057585 | Completed DMC

• 1 other identifier: 2020/33
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Anxiety; Pain

Keywords

Anxiety; Early ambulation; Bed exercise; Major surgery; Mobilization

Outcome Measures

Primary Outcomes (3)

• 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.

  0-15 minutes

• Pain level

  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

  It is the form in which the postoperative mobilization times are measured.

  0-15 minutes

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Behavioral: Turning in bed, arm and leg exercises

No treatment group

NO INTERVENTION

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.

Interventions

Turning in bed, arm and leg exercises BEHAVIORAL

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.

Exercise group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gurkan Kapikiran: lead

Study Sites (1)

Turgut Ozal Medical Center

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Beds

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies, Hospital; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This research was conducted as a prospective and experimental study

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 27, 2021
• Study Start: January 15, 2020
• Primary Completion: May 30, 2020
• Study Completion: April 10, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)