PainNCT06326125
Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures
A study testing TICK-B, TKTX-Cream and TICK-B and TKTX-C in people with Pain, run by Uppsala University at 1 site in Iraq.
Trial summary
This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- TICK-B, TKTX-Cream and TICK-B and TKTX-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIraq
- Study dates
- 15 Dec 2023to 10 Apr 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
- Healthy volunteers accepted
- Child
Who may be able to join
- School-aged 6-12 years old. Children who require PIVC.
Who cannot join
- Chronic diseases,
- Physical impairment,
- Disability contributes to difficult communication,
- Children of unsatisfied parents,
- Children with neurodevelopment delays,
- Cognitive impairment, hearing impairment, or visual impairment,
- Taking an analgesic within 6 hours, or those with a syncope history.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Examining the Effectiveness of Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures
This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture
Read the detailed description
Children frequently undergo unexpected and procedure-related pain while in hospital settings, leading to adverse emotional and psychological effects. The exposure to painful procedures, particularly venipuncture, commonly occurs in emergency units, upon admission, during hospital stays, or during follow-up visits. The mere act of inserting needles stands out as one of the most distressing medical procedures for children, resulting in frightening and upsetting experiences for both the children and their parents throughout the hospitalization period.
In the realm of pain management, interventions can generally be classified into pharmacological and non-pharmacological approaches. Within pharmacological interventions, local anesthetics play a key role in addressing needle-related pain. These anesthetics can permeate the cuticle and epidermal layers of intact skin, reaching the dermis where nerve endings are situated, thereby alleviating pain. Notably, a eutectic mixture of local anesthetics (EMLA) emulsion, composed of 25 mg lidocaine and 25 mg prilocaine per gram, has been explored in pediatric settings for managing venipuncture pain due to its effectiveness and minimally invasive nature.
On the non-pharmacological front, various strategies have been investigated for needle procedures in children, including distraction techniques, cognitive and behavioral therapy, hypnosis, and memory alteration. Among these interventions, distraction stands out as a straightforward method that can be promptly applied and requires minimal prior training. A systematic review has demonstrated the effectiveness of distraction in alleviating pain associated with needle-related procedures.
- Conditions
- Pain
- Being tested
- TICK-B, TKTX-Cream, TICK-B and TKTX-C
- Keywords
- pain, anxiety, painful procedures
- 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.
TICK-BBehavioural
TICK-B as art-based distraction
TKTX-CreamDrug
Also called Local anesthesia
TKTX-Cream as local anesthesia cream
TICK-B and TKTX-COther
Also called Combination approach
TICK-B and TkTx-C as combined intervention approche (pharmacology and non-pharmacology)
| Study group | Role | What they receive |
|---|---|---|
| TICK-B | Experimental | active distraction technique as non-pharmacology in treating children's pain and fear during venipuncture procedure. Receives: Behavioral: TICK-B |
| TkTx-Cream | Experimental | as Pharmacological approach will be use in managing children's pain and fear during venipuncture procedure. Receives: Drug: TKTX-Cream |
| TICK-B and TkTx-C | Experimental | Pharmacological approache and non-Pharmacological will be use in managing children's pain and fear during venipuncture procedure. Receives: Other: TICK-B and TKTX-C |
| Control Group | No intervention | No intervention will applied in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of Pain
Severity of pain will be assessed using Wong-Baker FACES Pain Rating Scale, a validated self-reporting tool widely utilized in clinical settings. Participants will be instructed to rate their pain on a scale from 0 (indicating no pain) to 10 (representing the worst imaginable pain). The Wong-Baker FACES Pain Rating Scale will be administered promptly after the completion of the procedure.
Measured: baseline, during, and immediately post-procedure.
Secondary outcomes (1)
Fear
level of fear will be assessed using the Child Fear Scale (CFS), a validated instrument designed to measure the level of fear in pediatric populations. Participants will be asked to express their feelings of fear related to the procedure through the Child Fear Scale.
Measured: baseline, during, and immediately post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start15 Dec 2023
- Primary completion10 Apr 2024 (estimated)
- Study completion10 Apr 2024 (estimated)
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 Uppsala UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherzad Khudeida Suleman, Uppsala University
- Investigators
- Sherzad Suleman, MsC, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326125
- Sponsor's protocol ID
- SherzadSH
- Status last verified
- Mar 2024
- First submitted
- 16 Feb 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suleman SK, Yahya N, Nilsson S, Enskar K. Comparative efficacy of pharmacological and non-pharmacological interventions for mitigating pain and anxiety associated with venipuncture: a randomised controlled trial. BMJ Paediatr Open. 2024 Sep 9;8(1):e002881. doi: 10.1136/bmjpo-2024-002881.
PubMed 39251366
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Examining the Effectiveness of Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures
- ClinicalTrials.gov ID
- NCT06326125
- Acronym / sponsor ID
- SherzadSH
- Conditions
- Pain
- Keywords
- pain, anxiety, painful procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 10 Apr 2024 (estimated)
- Study completion
- 10 Apr 2024 (estimated)
- First posted
- 22 Mar 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 study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture
Detailed description
Children frequently undergo unexpected and procedure-related pain while in hospital settings, leading to adverse emotional and psychological effects. The exposure to painful procedures, particularly venipuncture, commonly occurs in emergency units, upon admission, during hospital stays, or during follow-up visits. The mere act of inserting needles stands out as one of the most distressing medical procedures for children, resulting in frightening and upsetting experiences for both the children and their parents throughout the hospitalization period.
In the realm of pain management, interventions can generally be classified into pharmacological and non-pharmacological approaches. Within pharmacological interventions, local anesthetics play a key role in addressing needle-related pain. These anesthetics can permeate the cuticle and epidermal layers of intact skin, reaching the dermis where nerve endings are situated, thereby alleviating pain. Notably, a eutectic mixture of local anesthetics (EMLA) emulsion, composed of 25 mg lidocaine and 25 mg prilocaine per gram, has been explored in pediatric settings for managing venipuncture pain due to its effectiveness and minimally invasive nature.
On the non-pharmacological front, various strategies have been investigated for needle procedures in children, including distraction techniques, cognitive and behavioral therapy, hypnosis, and memory alteration. Among these interventions, distraction stands out as a straightforward method that can be promptly applied and requires minimal prior training. A systematic review has demonstrated the effectiveness of distraction in alleviating pain associated with needle-related procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TICK-B | Experimental | Behavioral: TICK-Bactive distraction technique as non-pharmacology in treating children's pain and fear during venipuncture procedure. |
| TkTx-Cream | Experimental | Drug: TKTX-Creamas Pharmacological approach will be use in managing children's pain and fear during venipuncture procedure. |
| TICK-B and TkTx-C | Experimental | Other: TICK-B and TKTX-CPharmacological approache and non-Pharmacological will be use in managing children's pain and fear during venipuncture procedure. |
| Control Group | No intervention | –No intervention will applied in this group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- School-aged 6-12 years old. Children who require PIVC.
Key exclusion criteria (7 listed)
- Chronic diseases,
- Physical impairment,
- Disability contributes to difficult communication,
- Children of unsatisfied parents,
- Children with neurodevelopment delays,
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 |
|---|---|---|
| TICK-BTICK-B as art-based distraction | Behavioural | TICK-B |
| TKTX-CreamAlso: Local anesthesiaTKTX-Cream as local anesthesia cream | Drug | TkTx-Cream |
| TICK-B and TKTX-CAlso: Combination approachTICK-B and TkTx-C as combined intervention approche (pharmacology and non-pharmacology) | Other | TICK-B and TkTx-C |
Primary outcome
severity of Pain
Time frame: baseline, during, and immediately post-procedure.
Severity of pain will be assessed using Wong-Baker FACES Pain Rating Scale, a validated self-reporting tool widely utilized in clinical settings. Participants will be instructed to rate their pain on a scale from 0 (indicating no pain) to 10 (representing the worst imaginable pain). The Wong-Baker FACES Pain Rating Scale will be administered promptly after the completion of the procedure.
1 secondary outcome
Fear
Time frame: baseline, during, and immediately post-procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 39251366Suleman SK, Yahya N, Nilsson S, Enskar K. Comparative efficacy of pharmacological and non-pharmacological interventions for mitigating pain and anxiety associated with venipuncture: a randomised controlled trial. BMJ Paediatr Open. 2024 Sep 9;8(1):e002881. doi: 10.1136/bmjpo-2024-002881.
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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.
Sherzad Suleman, MsC principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TICK-B, TKTX-Cream and TICK-B and TKTX-C in people with Pain, run by Uppsala University at 1 site in Iraq.
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 7 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: status not confirmed, as of the sponsor's last update on 28 Mar 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 Iraq. 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?
Results are not available in the source record.
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?
severity of Pain (time frame: baseline, during, and immediately post-procedure.). 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 NCT06326125, 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 28 Mar 2024.