The Effect of Range of Motion (ROM) exercıses on Comfort Level and vıtal sıgns

The Effect of Range of Motion (ROM) Exercises Applied to Oncology Patients in the 6-12 Years Group on the Comfort Level and Vital Signs

This experimental study aims to examine the effects of ROM (Range of Motion) exercises on comfort level and vital signs in children diagnosed with cancer.

Study Overview

• Status: Completed
• Conditions: Children With Cancer
• Intervention / Treatment: Other: Range Of Motion applied group

Detailed Description

The sample of the study consisted of a total of 60 oncology patient children, 30 in the experimental group and 30 in the control group, between the ages of 6-12, who were hospitalized in the Pediatric Bone Marrow Transplant Unit and Pediatric Hematology Oncology Service of a state hospital. The data of the study were collected with the "Data Collection Form", "Life Findings Table" and "Comfort Scale in Children". Range of motion exercise applications continued once a day for 5 days a week for approximately 20 minutes. Fever, pulse, respiration, blood pressure, pain and comfort levels of the children were measured before and after the exercise. In the study, it was investigated whether Range of motion exercises have an effect on vital signs and comfort levels of children with cancer.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beykoz
    • Istanbul, Beykoz, Turkey, 34810
      • Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals between 6 and 12 years of age.
• Patients diagnosed with oncology.
• Patients who agreed to participate in the study and whose consent was obtained from their parents.
• Patients who can communicate and are conscious.

Exclusion Criteria:

• Patients with fractures or orthopedic conditions that may limit exercise.
• Patients with serious cardiac problems that may prevent exercise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Range Of Motion applied group; Children with cancer were given Range Of Motion exercises once a day for 5 days for approximately 20 minutes.	Other: Range Of Motion applied group; Range Of Motion was applied once a day for approximately 20 minutes for 5 days.
No Intervention: Control group; Children with cancer in this group received no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature	For 5 days, children's body temperature was taken 2 times before and after 20 minutes of Range Of Motion.	For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
Pulse	For 5 days, children's pulse was taken 2 times before and after 20 minutes of Range Of Motion.	For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
Respiration	For 5 days, children's Respiration was taken 2 times before and after 20 minutes of Range Of Motion.	For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
Blood pressure	For 5 days, children's Blood pressure was taken 2 times before and after 20 minutes of Range Of Motion.	For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
Comfort	For 5 days, children's comfort level was taken 2 times before and after 20 minutes of Range Of Motion. Pediatric Comfort Assessment Scale was used for measurement. It evaluates 5 parameters: sounds, motor movements, performance, facial expressions and other. Each item is evaluated on a 5-point Likert scale from 0 to 4 (0/Not Available, 1/No, 2/Somewhat, 3/Moderate, 4/Strong) from bad to good. Higher scores indicate a higher level of comfort.	For 5 days/ 2 times a day/ before and after a 20 minute range of motion.

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Aysel Kokcu Dogan, Asst. Prof., Istanbul Medipol University faculty member

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: pediatrics; cancer; comfort; Range Of Motion exercises
• Other Study ID Numbers: E-10840098-772.02-7434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No