CClinicalTrials.gg
CompletedNCT06584019Updated Sep 19, 2024

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

An interventional study of Range Of Motion applied group in Children With Cancer, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled May 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Children With Cancer

Keywords

  • Range Of Motion exercises
  • cancer
  • pediatrics
  • comfort
03

In context

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with fractures or orthopedic conditions that may limit exercise.
  • Patients with serious cardiac problems that may prevent exercise.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

    Children with cancer in this group received no intervention.

Interventions

  • OtherRange Of Motion applied group

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

06

What researchers measure

Primary outcomes

  1. Body temperature

    For 5 days, children's body temperature was taken 2 times before and after 20 minutes of Range Of Motion.

    Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.

  2. Pulse

    For 5 days, children's pulse was taken 2 times before and after 20 minutes of Range Of Motion.

    Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.

  3. Respiration

    For 5 days, children's Respiration was taken 2 times before and after 20 minutes of Range Of Motion.

    Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.

  4. 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.

    Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.

  5. 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.

    Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.

07

Study locations

1 site
  • Medipol University
    Istanbul, Beykoz 34810, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06584019
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
aysel kokcudogan (Ph.D., Asst. Prof., Istanbul Medipol University Hospital) — Principal investigator
First posted
Sep 4, 2024
Start date
May 1, 2023
Primary completion
Dec 30, 2023
Completion
Jul 1, 2024
Last update
Sep 19, 2024

Study contacts

Aysel Kokcu Dogan, Asst. Prof.
study director · Istanbul Medipol University faculty member

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion