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

NCT06584019 | Completed

• 1 other identifier: E-10840098-772.02-7434
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Children With Cancer

Keywords

Range Of Motion exercises; cancer; pediatrics; comfort

Outcome Measures

Primary Outcomes (5)

• 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 systolic blood pressure and diastolic 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.

Study Arms (2)

Range Of Motion applied group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Children with cancer in this group received no intervention.

Interventions

Range Of Motion applied group OTHER

Range Of Motion was applied once a day for approximately 20 minutes for 5 days.

Range Of Motion applied group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Aysel Kokcu Dogan, Asst. Prof.

  Istanbul Medipol University faculty member

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Asst. Prof.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: September 4, 2024
• Study Start: May 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: July 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)