Child, OnlyNCT06241690
Cold Applications on the Pain Level of Children With Sutures
A study testing the cold applications in post-suture pain reduces the child's pain in people with Child, Only, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Purpose:This research was conducted as an experimental study with pretest and posttest control groups in order to evaluate the effect of post-suture cold applications on the pain level of children with sutures. Design and Methods: This study is a randomised controlled study. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Child, Only
- What is being tested?
- the cold applications in post-suture pain reduces the child's pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2021to 20 Jul 2022
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parents who agreed to participate in the study
Who cannot join
- -visually impaired child
- mentally retarded child
- speech impaired children
- without chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Post-suture Cold Applications on the Pain Level of Children With Sutures
Purpose:This research was conducted as an experimental study with pretest and posttest control groups in order to evaluate the effect of post-suture cold applications on the pain level of children with sutures.
Design and Methods: This study is a randomised controlled study. In the study, there were 150 children in the experimental group and 150 children in the control group.
Read the detailed description
The experimental groups was applied at the 1st, 2nd and 6th hours after the suture application in the cold applications The different practitioners applied in the Visual Analog Scale after and before in the cold applications to the experimental and control groups
- Conditions
- Child, Only
- Being tested
- the cold applications in post-suture pain reduces the child's pain
- Keywords
- Cold Application, child, Nurse, Pain, suture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the cold applications in post-suture pain reduces the child's painOther
The experimental groups was applied cold applications immediately after 20 minutes the suture. Later, The experimental groups was applied cold applications again for 20 minutes 1 hour, 2 hours and 6 hours after the suture.
| Study group | Role | What they receive |
|---|---|---|
| the cold applications in post-suture pain reduces the child's pain | Experimental | The population of the study consists of children aged 12-17 who were treated in the pediatric emergency departments of the designated hospitals between December 2021 and July 2022 and met the working criteria. The sample consists of 300 children who applied to the pediatric emergency service between December 2021 and July 2022 and met the research criteria. Socio-Demographic presentation form and Visual Analog Scale were used as data collection tools. Statistical analysis of the data was made in SPSS 22 package program. Receives: Other: the cold applications in post-suture pain reduces the child's pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
this study was measured the effects of cold application in the children after the suture
The experimental groups was applied cold applications immediately after 20 minutes the suture. Later, The experimental groups was applied cold applications again for 20 minutes 1 hour, 2 hours and 6 hours after the suture. The visual Analog Scale were used as data collection tools. The Visual Analog Scale scale was applied before suturing. It was then applied 20 minutes, 1 hour, 2 hours and 6 hours after the suturing procedure.
The Visual Analog Scale: A minimum of 0 and a maximum of 10 points are obtained from the scale. A high score from the scale indicates a high level of pain
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start11 Nov 2021
- Primary completion15 Dec 2021
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİDEM COŞKUN ŞİMŞEK, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241690
- Sponsor's protocol ID
- post-suture cold applications
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Post-suture Cold Applications on the Pain Level of Children With Sutures
- ClinicalTrials.gov ID
- NCT06241690
- Acronym / sponsor ID
- post-suture cold applications
- Conditions
- Child, Only
- Keywords
- Cold Application, child, Nurse, Pain, suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 5 Feb 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.
Purpose:This research was conducted as an experimental study with pretest and posttest control groups in order to evaluate the effect of post-suture cold applications on the pain level of children with sutures.
Design and Methods: This study is a randomised controlled study. In the study, there were 150 children in the experimental group and 150 children in the control group.
Detailed description
The experimental groups was applied at the 1st, 2nd and 6th hours after the suture application in the cold applications The different practitioners applied in the Visual Analog Scale after and before in the cold applications to the experimental and control groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the cold applications in post-suture pain reduces the child's pain | Experimental | Other: the cold applications in post-suture pain reduces the child's painThe population of the study consists of children aged 12-17 who were treated in the pediatric emergency departments of the designated hospitals between December 2021 and July 2022 and met the working criteria. The sample consists of 300 children who applied to the pediatric emergency service between December 2021 and July 2022 and met the research criteria. Socio-Demographic presentation form and Visual Analog Scale were used as data collection tools. Statistical analysis of the data was made in SPSS 22 package program. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- parents who agreed to participate in the study
Key exclusion criteria (4 listed)
- -visually impaired child
- mentally retarded child
- speech impaired children
- without chronic disease
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 |
|---|---|---|
| the cold applications in post-suture pain reduces the child's painThe experimental groups was applied cold applications immediately after 20 minutes the suture. Later, The experimental groups was applied cold applications again for 20 minutes 1 hour, 2 hours and 6 hours after the suture. | Other | the cold applications in post-suture pain reduces the child's pain |
Primary outcome
this study was measured the effects of cold application in the children after the suture
Time frame: 1 days
The experimental groups was applied cold applications immediately after 20 minutes the suture. Later, The experimental groups was applied cold applications again for 20 minutes 1 hour, 2 hours and 6 hours after the suture. The visual Analog Scale were used as data collection tools. The Visual Analog Scale scale was applied before suturing. It was then applied 20 minutes, 1 hour, 2 hours and 6 hours after the suturing procedure. The Visual Analog Scale: A minimum of 0 and a maximum of 10 points are obtained from the scale. A high score from the scale indicates a high level of pain
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 5 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the cold applications in post-suture pain reduces the child's pain in people with Child, Only, run by Firat University 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 1 inclusion and 4 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 5 Feb 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?
this study was measured the effects of cold application in the children after the suture (time frame: 1 days). 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 5 Feb 2024.