PainNCT05823324
The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation
A study testing Therapeutic play group in people with Pain and Anxiety, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
Therapeutic play (TP) is a non-pharmacological method used in the pain management in children. This study was conducted to determine the effect of therapeutic play on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation (PIVC). Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- What is being tested?
- Therapeutic play group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Jun 2020
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-6 year-old children,
- had no mental disability,
- were able to communicate,
- and had mothers volunteered to participate
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University-Cerrahpaşa
Istanbul, 34381
Seda Caglar
Istanbul, 34381
About this study
Official title: The Effect of Therapeutic Play on Children's Pain, Anxiety, and Mothers' Anxiety During Peripheral Intravenous Catheterisation
Therapeutic play (TP) is a non-pharmacological method used in the pain management in children. This study was conducted to determine the effect of therapeutic play on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation (PIVC).
Read the detailed description
The hospitalisation of children due to an acute or chronic illness interrupts play, disrupts their daily routines, places them in an unfamiliar environment, forces them to encounter with unfamiliar people, exposes them to invasive procedures, and makes them suffer from pain and anxiety. Peripheral intravenous catheterisation (PIVC) is probably the most common procedure performed in paediatric clinics. It has been estimated that 80% of hospitalised children have a peripheral intravenous catheter in place. PIVC is a painful and traumatic experience that children usually go through for the first time and frequently during the hospitalisation. This experience of children impairs effective communication between them and healthcare professionals and also causes problems in adaptation to the care and treatment process in the hospital setting. As one of the non-pharmacological pain relief methods, therapeutic play (TP) is a distraction that is defined as "the directed use of toys and materials, which can facilitate children to gain knowledge about the environment and the world they live in, to improve their perceptions thereof and to gain control, for a specific purpose". In order to call play with a child who is hospitalised as therapeutic, the play should encourage children to express their feelings and thoughts during the hospitalisation, assume an educational role in their positive or negative hospital experiences, and bring psychosocial and physical benefits. Children could be told facts such as the hospitalisation, the procedures to be followed and the time when this procedure would end through therapeutic play
- Being tested
- Therapeutic play group
- Keywords
- pain, anxiety, Peripheral intravenous catheterisation, therapeutic play
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic play groupBehavioural
The dramatization method with teddy bear, one of the TP methods, was applied during the PIVC intervention
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic play | Experimental | The therapeutic play method with the teddy bear during PIVC was applied in this group Receives: Behavioral: Therapeutic play group |
| Control | No intervention | The standard procedure of the clinic was applied in the control group. The routine invasive procedure of the clinic, the mothers accompany their children and are involved in the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation
The FLACC Scale was used to assess the pain scores of children. The scale is scored between 0 and 10 points indicating "0": the child is relaxed and calm, "1-3": the child is mildly uncomfortable, "4-6": the child has moderate pain and "7-10": the child has severe pain.
Measured: data collected just before and within 5 min after peripheral intravenous catheterization procedure
Change from before in anxiety on the CEMS Scale at during peripheral intravenous catheterization
The CEMS scale was used to evaluate the anxiety scores of children.This scale, which consists of 5 different categories and 25 items, was used to evaluate the anxiety of children before and during medical procedures. Total score ranges between 5 and 25 points
Measured: data collected just before and within 5 min after peripheral intravenous catheterization procedure
Secondary outcomes (1)
Change from before in mothers' anxiety on STAI scale at during peripheral intravenous catheterization
The STAI scale was used to assess the anxiety mean scores of the mothers.This self-assessment scale with brief statements comprises a total of 40 items, including 20 items in each of two sections, the "state anxiety inventory" and the "trait anxiety inventory". The 'State Anxiety Inventory' was designed to determine what was felt at that moment and the 'Trait Anxiety Scale' was designed to determine what was felt in the last week.
Measured: data collected just before and within 5 min after peripheral intravenous catheterization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Feb 2020
- Primary completion1 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Caglar, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823324
- Sponsor's protocol ID
- SeCaglar
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderoglu S, Caglar S. The effect of therapeutic play with teddy bear on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation: a randomised clinical trial. BMC Pediatr. 2025 Dec 6;26(1):29. doi: 10.1186/s12887-025-05769-4.
PubMed 41351041
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Play on Children's Pain, Anxiety, and Mothers' Anxiety During Peripheral Intravenous Catheterisation
- ClinicalTrials.gov ID
- NCT05823324
- Acronym / sponsor ID
- SeCaglar
- Keywords
- pain, anxiety, Peripheral intravenous catheterisation, therapeutic play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 21 Apr 2023 (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.
Therapeutic play (TP) is a non-pharmacological method used in the pain management in children. This study was conducted to determine the effect of therapeutic play on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation (PIVC).
Detailed description
The hospitalisation of children due to an acute or chronic illness interrupts play, disrupts their daily routines, places them in an unfamiliar environment, forces them to encounter with unfamiliar people, exposes them to invasive procedures, and makes them suffer from pain and anxiety. Peripheral intravenous catheterisation (PIVC) is probably the most common procedure performed in paediatric clinics. It has been estimated that 80% of hospitalised children have a peripheral intravenous catheter in place. PIVC is a painful and traumatic experience that children usually go through for the first time and frequently during the hospitalisation. This experience of children impairs effective communication between them and healthcare professionals and also causes problems in adaptation to the care and treatment process in the hospital setting. As one of the non-pharmacological pain relief methods, therapeutic play (TP) is a distraction that is defined as "the directed use of toys and materials, which can facilitate children to gain knowledge about the environment and the world they live in, to improve their perceptions thereof and to gain control, for a specific purpose". In order to call play with a child who is hospitalised as therapeutic, the play should encourage children to express their feelings and thoughts during the hospitalisation, assume an educational role in their positive or negative hospital experiences, and bring psychosocial and physical benefits. Children could be told facts such as the hospitalisation, the procedures to be followed and the time when this procedure would end through therapeutic play
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic play | Experimental | Behavioral: Therapeutic play groupThe therapeutic play method with the teddy bear during PIVC was applied in this group |
| Control | No intervention | –The standard procedure of the clinic was applied in the control group. The routine invasive procedure of the clinic, the mothers accompany their children and are involved in the procedure |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3-6 year-old children,
- had no mental disability,
- were able to communicate,
- and had mothers volunteered to participate
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Therapeutic play groupThe dramatization method with teddy bear, one of the TP methods, was applied during the PIVC intervention | Behavioural | Therapeutic play |
Primary outcome
Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation
Time frame: data collected just before and within 5 min after peripheral intravenous catheterization procedure
The FLACC Scale was used to assess the pain scores of children. The scale is scored between 0 and 10 points indicating "0": the child is relaxed and calm, "1-3": the child is mildly uncomfortable, "4-6": the child has moderate pain and "7-10": the child has severe pain.
Change from before in anxiety on the CEMS Scale at during peripheral intravenous catheterization
Time frame: data collected just before and within 5 min after peripheral intravenous catheterization procedure
The CEMS scale was used to evaluate the anxiety scores of children.This scale, which consists of 5 different categories and 25 items, was used to evaluate the anxiety of children before and during medical procedures. Total score ranges between 5 and 25 points
1 secondary outcome
Change from before in mothers' anxiety on STAI scale at during peripheral intravenous catheterization
Time frame: data collected just before and within 5 min after peripheral intravenous catheterization procedure
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 21 Apr 2023.
- Derived from this study: PubMed 41351041Anderoglu S, Caglar S. The effect of therapeutic play with teddy bear on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation: a randomised clinical trial. BMC Pediatr. 2025 Dec 6;26(1):29. doi: 10.1186/s12887-025-05769-4.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic play group in people with Pain and Anxiety, run by Istanbul University - Cerrahpasa at 2 sites 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 1 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation (time frame: data collected just before and within 5 min after peripheral intravenous catheterization procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05823324, which also lists 1 linked publication.
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 21 Apr 2023.