Children With CancerNCT06584019
The Effect of Range of Motion (ROM) exercıses on Comfort Level and vıtal sıgns
A study testing Range Of Motion applied group in people with Children With Cancer, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Children With Cancer
- What is being tested?
- Range Of Motion applied group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Patients with fractures or orthopedic conditions that may limit exercise.
- Patients with serious cardiac problems that may prevent exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Children With Cancer
- Being tested
- Range Of Motion applied group
- Keywords
- Range Of Motion exercises, cancer, pediatrics, comfort
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Range Of Motion applied groupOther
Range Of Motion was applied once a day for approximately 20 minutes for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Range Of Motion applied group |
| Control group | No intervention | Children with cancer in this group received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
For 5 days, children's body temperature was taken 2 times before and after 20 minutes of Range Of Motion.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 May 2023
- Primary completion30 Dec 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysel kokcudogan, Istanbul Medipol University Hospital
- Investigators
- Aysel Kokcu Dogan, Asst. Prof., Study director, Istanbul Medipol University faculty member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584019
- Sponsor's protocol ID
- E-10840098-772.02-7434
- Status last verified
- Sep 2024
- First submitted
- 19 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06584019
- Acronym / sponsor ID
- E-10840098-772.02-7434
- Conditions
- Children With Cancer
- Keywords
- Range Of Motion exercises, cancer, pediatrics, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Range Of Motion applied group | Experimental | Other: Range Of Motion applied groupChildren with cancer were given Range Of Motion exercises once a day for 5 days for approximately 20 minutes. |
| Control group | No intervention | –Children with cancer in this group received no intervention. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with fractures or orthopedic conditions that may limit exercise.
- Patients with serious cardiac problems that may prevent exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Range Of Motion applied groupRange Of Motion was applied once a day for approximately 20 minutes for 5 days. | Other | Range Of Motion applied group |
Primary outcome
Body temperature
Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
For 5 days, children's body temperature was taken 2 times before and after 20 minutes of Range Of Motion.
Pulse
Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
For 5 days, children's pulse was taken 2 times before and after 20 minutes of Range Of Motion.
Respiration
Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
For 5 days, children's Respiration was taken 2 times before and after 20 minutes of Range Of Motion.
Blood pressure
Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
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.
Comfort
Time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysel Kokcu Dogan, Asst. Prof. study director
Istanbul Medipol University faculty member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Range Of Motion applied group in people with Children With Cancer, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.