Peripheral Intravenous CannulationNCT04977323
Comparison Effectiveness of Distractions on Pain and Fear of Children
A study testing TICK-B group in people with Peripheral Intravenous Cannulation, run by University of Witten/Herdecke.
Trial summary
Distraction is a non-pharmacological technique that moves focus away from anxiety, discomfort or unpleasant stimulation to more stimulating or friendly stimulation. Distraction is one of the most effective, simplest and inexpensive non-pharmacological pain management methods (Hockenberry \& Wilson, 2018). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Peripheral Intravenous Cannulation
- What is being tested?
- TICK-B group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2021to 10 Oct 2021
- 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
- School-aged 6-12 years old.
- Children who require PIVC.
Who cannot join
- Respiratory chronic diseases,
- Physical impairment,
- Disability contributing to difficult communication,
- Children of unsatisfied parents,
- Children with neurodevelopment delay,
- Cognitive impairment, hearing impairment or a visual impairment,
- Taking an analgesic within 6 hours, or for those with a syncope history.
About this study
Official title: Comparing The Effectiveness of Tracing Image and Coloring for Kids-Book With Two Passive Distractions on Pain and Fear in Children During Peripheral Intravenous Cannulation: A Randomized Controlled Trial
Distraction is a non-pharmacological technique that moves focus away from anxiety, discomfort or unpleasant stimulation to more stimulating or friendly stimulation. Distraction is one of the most effective, simplest and inexpensive non-pharmacological pain management methods (Hockenberry \& Wilson, 2018). The benefits of using non-pharmacological methods include decreased pain, distress, and fear reported by the parent, child, and/or observer (Wente, 2013). There are two main types of distraction techniques: active and passive (Mutlu \& Balcı, 2015; Wohlheiter \& Dahlquist, 2013).
Objectives:
Read more
To evaluate the roles of the TICK-B, listening music, and watching cartoon, in relieving pain and fear of school-age children during PIVC.
To compare the effect of TICK-B with the effects of the listening music, and watching cartoon, on reducing pain and fear during PIVC in children.
To compare the effects of three distraction groups with the control group in relieving pain and fear during PIVC.
Read the detailed description
Peripheral intravenous cannulation (PIVC) is an invasive technique. In this technique, a catheter is entrenched through the skin of the recipient into the lumen of a peripheral blood vein. It is the second most painful procedure performed in hospitals. Peripheral intravenous cannulation (PICV) is a common painful procedure for children, and nearly all ill children have experience with PIVC, and up to 80% of patients receive a peripheral venous cannula in a hospital. Therefore, the use of effective methods in pain and anxiety relief is very important during injection procedures in children.
In order to relieve pain and fear in children undergoing PICV. Psychological and physical approaches for coping with children's pain are favored, as well as pharmacological methods. Application of topical anesthetic creams is the most commonly used pharmacological solution to reduce pain associated with the medical procedure, or refrigerant preparations, however, only reduce the perception of pain in children during procedures. These approaches are not resolved anxiety, a core factor of noncooperation, which encumbers the efficiency of the needle procedure. For this cause, non-pharmacological approaches are generally recognized as alternative techniques, which may be used separately or in addition to pharmacological approaches, to provide sufficient pain and fear relief and to offer children a sense of control over the situation.
- Conditions
- Peripheral Intravenous Cannulation
- Being tested
- TICK-B group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TICK-B groupOther
Also called Watching cartoons, Listening to music group, Control group or no intervention
These interventions will use as distraction techniques.
| Study group | Role | What they receive |
|---|---|---|
| TICK-B group as intervention group | Experimental | TICK-B group: The children will receive the pictures they want. They will be asked to trace and color the pictures that need coloring. The nurse will color with children during the procedure. And after the procedure, the child will take his or her picture which he colored during the procedure. Receives: Other: TICK-B group |
| Watching cartoons | Experimental | Watching cartoons: In this group, children will watch cartoons as they like. Watching will continue until the procedure is complete. Receives: Other: TICK-B group |
| Group listening to music | Experimental | Listening to music: In this group, children will listen to cartoon music as they like. Listen will continue until the procedure is complete. Receives: Other: TICK-B group |
| Standard care provided group as control group | No intervention | Control group. The kids in this group will be allowed to keep their family near. The routine blood taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
To assess the intensity of pain related to Peripheral intravenous cannulation procedure in children:
Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
Measured: 5 minutes before procedure done.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
To assess the fear level of the children related to Peripheral intravenous cannulation procedure:
Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
Measured: 5 minutes before procedure done
Secondary outcomes (4)
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.
To assess the intensity of pain related to Peripheral intravenous cannulation procedure in children:
Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
Measured: 0 minute during peripheral cannulation insertion procedure(time during insertion of cannula).
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.
To assess the intensity of pain related to peripheral intravenous cannulation procedure in children:
Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
Measured: 1-2 minutes after procedure done.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
To assess the fear level of the children related to peripheral intravenous cannulation procedure:
-Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
Measured: 0 minute during cannulation procedure.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
To assess the fear level of the children related to peripheral intravenous cannulation procedure:
-Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
Measured: 1-2 minute after cannulation procedure done.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start28 Jul 2021 (estimated)
- Primary completion5 Oct 2021 (estimated)
- Study completion10 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Peripheral Intravenous CannulationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherzad Khudeida Suleman, University of Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977323
- Sponsor's protocol ID
- Sherzad
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hockenberry, M. J., & Wilson, D. (2018). Wong's nursing care of infants and children-E-book. Elsevier Health Sciences.
Wente SJ. Nonpharmacologic pediatric pain management in emergency departments: a systematic review of the literature. J Emerg Nurs. 2013 Mar;39(2):140-50. doi: 10.1016/j.jen.2012.09.011. Epub 2012 Nov 28.
PubMed 23199786Mutlu B, Balci S. Effects of balloon inflation and cough trick methods on easing pain in children during the drawing of venous blood samples: a randomized controlled trial. J Spec Pediatr Nurs. 2015 Jul;20(3):178-86. doi: 10.1111/jspn.12112. Epub 2015 Mar 28.
PubMed 25817062Hendry F, Checketts MR, McLeod GA. Effect of intradermal anaesthesia on success rate and pain of intravenous cannulation: a randomized non-blind crossover study. Scott Med J. 2011 Nov;56(4):210-3. doi: 10.1258/smj.2011.011160.
PubMed 22089042Rogers TL, Ostrow CL. The use of EMLA cream to decrease venipuncture pain in children. J Pediatr Nurs. 2004 Feb;19(1):33-9. doi: 10.1016/j.pedn.2003.09.005.
PubMed 14963868Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif. 2006 Jan;30(1):24-49. doi: 10.1177/0145445505282438.
PubMed 16330518Friedrichsdorf SJ, Eull D, Weidner C, Postier A. A hospital-wide initiative to eliminate or reduce needle pain in children using lean methodology. Pain Rep. 2018 Sep 11;3(Suppl 1):e671. doi: 10.1097/PR9.0000000000000671. eCollection 2018 Sep.
PubMed 30324169Shomaker K, Dutton S, Mark M. Pain Prevalence and Treatment Patterns in a US Children's Hospital. Hosp Pediatr. 2015 Jul;5(7):363-70. doi: 10.1542/hpeds.2014-0195.
PubMed 26136310Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.
PubMed 18387963
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing The Effectiveness of Tracing Image and Coloring for Kids-Book With Two Passive Distractions on Pain and Fear in Children During Peripheral Intravenous Cannulation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04977323
- Acronym / sponsor ID
- Sherzad
- Conditions
- Peripheral Intravenous Cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- 28 Jul 2021 (estimated)
- Primary completion
- 5 Oct 2021 (estimated)
- Study completion
- 10 Oct 2021 (estimated)
- First posted
- 26 Jul 2021 (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.
Distraction is a non-pharmacological technique that moves focus away from anxiety, discomfort or unpleasant stimulation to more stimulating or friendly stimulation. Distraction is one of the most effective, simplest and inexpensive non-pharmacological pain management methods (Hockenberry \& Wilson, 2018). The benefits of using non-pharmacological methods include decreased pain, distress, and fear reported by the parent, child, and/or observer (Wente, 2013). There are two main types of distraction techniques: active and passive (Mutlu \& Balcı, 2015; Wohlheiter \& Dahlquist, 2013).
Objectives:
To evaluate the roles of the TICK-B, listening music, and watching cartoon, in relieving pain and fear of school-age children during PIVC.
To compare the effect of TICK-B with the effects of the listening music, and watching cartoon, on reducing pain and fear during PIVC in children.
To compare the effects of three distraction groups with the control group in relieving pain and fear during PIVC.
Detailed description
Peripheral intravenous cannulation (PIVC) is an invasive technique. In this technique, a catheter is entrenched through the skin of the recipient into the lumen of a peripheral blood vein. It is the second most painful procedure performed in hospitals. Peripheral intravenous cannulation (PICV) is a common painful procedure for children, and nearly all ill children have experience with PIVC, and up to 80% of patients receive a peripheral venous cannula in a hospital. Therefore, the use of effective methods in pain and anxiety relief is very important during injection procedures in children.
In order to relieve pain and fear in children undergoing PICV. Psychological and physical approaches for coping with children's pain are favored, as well as pharmacological methods. Application of topical anesthetic creams is the most commonly used pharmacological solution to reduce pain associated with the medical procedure, or refrigerant preparations, however, only reduce the perception of pain in children during procedures. These approaches are not resolved anxiety, a core factor of noncooperation, which encumbers the efficiency of the needle procedure. For this cause, non-pharmacological approaches are generally recognized as alternative techniques, which may be used separately or in addition to pharmacological approaches, to provide sufficient pain and fear relief and to offer children a sense of control over the situation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TICK-B group as intervention group | Experimental | Other: TICK-B groupTICK-B group: The children will receive the pictures they want. They will be asked to trace and color the pictures that need coloring. The nurse will color with children during the procedure. And after the procedure, the child will take his or her picture which he colored during the procedure. |
| Watching cartoons | Experimental | Other: TICK-B groupWatching cartoons: In this group, children will watch cartoons as they like. Watching will continue until the procedure is complete. |
| Group listening to music | Experimental | Other: TICK-B groupListening to music: In this group, children will listen to cartoon music as they like. Listen will continue until the procedure is complete. |
| Standard care provided group as control group | No intervention | –Control group. The kids in this group will be allowed to keep their family near. The routine blood taking |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- School-aged 6-12 years old.
- Children who require PIVC.
Key exclusion criteria (7 listed)
- Respiratory chronic diseases,
- Physical impairment,
- Disability contributing to difficult communication,
- Children of unsatisfied parents,
- Children with neurodevelopment delay,
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-B groupAlso: Watching cartoons, Listening to music group, Control group or no interventionThese interventions will use as distraction techniques. | Other | Group listening to music, TICK-B group as intervention group, Watching cartoons |
Primary outcome
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
Time frame: 5 minutes before procedure done.
To assess the intensity of pain related to Peripheral intravenous cannulation procedure in children: Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
Time frame: 5 minutes before procedure done
To assess the fear level of the children related to Peripheral intravenous cannulation procedure: Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
4 secondary outcomes
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.
Time frame: 0 minute during peripheral cannulation insertion procedure(time during insertion of cannula).
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.
Time frame: 1-2 minutes after procedure done.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
Time frame: 0 minute during cannulation procedure.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
Time frame: 1-2 minute after cannulation procedure done.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- BackgroundHockenberry, M. J., & Wilson, D. (2018). Wong's nursing care of infants and children-E-book. Elsevier Health Sciences.
- Background: PubMed 23199786Wente SJ. Nonpharmacologic pediatric pain management in emergency departments: a systematic review of the literature. J Emerg Nurs. 2013 Mar;39(2):140-50. doi: 10.1016/j.jen.2012.09.011. Epub 2012 Nov 28.
- Background: PubMed 25817062Mutlu B, Balci S. Effects of balloon inflation and cough trick methods on easing pain in children during the drawing of venous blood samples: a randomized controlled trial. J Spec Pediatr Nurs. 2015 Jul;20(3):178-86. doi: 10.1111/jspn.12112. Epub 2015 Mar 28.
- Background: PubMed 22089042Hendry F, Checketts MR, McLeod GA. Effect of intradermal anaesthesia on success rate and pain of intravenous cannulation: a randomized non-blind crossover study. Scott Med J. 2011 Nov;56(4):210-3. doi: 10.1258/smj.2011.011160.
- Background: PubMed 14963868Rogers TL, Ostrow CL. The use of EMLA cream to decrease venipuncture pain in children. J Pediatr Nurs. 2004 Feb;19(1):33-9. doi: 10.1016/j.pedn.2003.09.005.
- Background: PubMed 16330518Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif. 2006 Jan;30(1):24-49. doi: 10.1177/0145445505282438.
- Background: PubMed 30324169Friedrichsdorf SJ, Eull D, Weidner C, Postier A. A hospital-wide initiative to eliminate or reduce needle pain in children using lean methodology. Pain Rep. 2018 Sep 11;3(Suppl 1):e671. doi: 10.1097/PR9.0000000000000671. eCollection 2018 Sep.
- Background: PubMed 26136310Shomaker K, Dutton S, Mark M. Pain Prevalence and Treatment Patterns in a US Children's Hospital. Hosp Pediatr. 2015 Jul;5(7):363-70. doi: 10.1542/hpeds.2014-0195.
- Background: PubMed 18387963Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TICK-B group in people with Peripheral Intravenous Cannulation, run by University of Witten/Herdecke.
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 2 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain (time frame: 5 minutes before procedure done.). 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 NCT04977323, which also lists 9 linked publications.
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 3 Aug 2021.