Comparison Effectiveness of Distractions on Pain and Fear of Children

NCT ID: NCT04977323

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2021-10-10

Brief 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). 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.

Conditions

Peripheral Intravenous Cannulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

TICK-B group as intervention group

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.

Group Type: EXPERIMENTAL

TICK-B group

Intervention Type: OTHER

These interventions will use as distraction techniques.

Watching cartoons

Watching cartoons: In this group, children will watch cartoons as they like. Watching will continue until the procedure is complete.

Group Type: EXPERIMENTAL

TICK-B group

Intervention Type: OTHER

These interventions will use as distraction techniques.

Group listening to music

Listening to music: In this group, children will listen to cartoon music as they like. Listen will continue until the procedure is complete.

Group Type: EXPERIMENTAL

TICK-B group

Intervention Type: OTHER

These interventions will use as distraction techniques.

Standard care provided group as control group

Control group. The kids in this group will be allowed to keep their family near. The routine blood taking

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TICK-B group

These interventions will use as distraction techniques.

Intervention Type: OTHER

Other Intervention Names

Watching cartoons; Listening to music group; Control group or no intervention

Eligibility Criteria

Inclusion Criteria

• School-aged 6-12 years old.
• Children who require PIVC.

Exclusion Criteria

1. Respiratory chronic diseases,

2. Physical impairment,

3. Disability contributing to difficult communication,

4. Children of unsatisfied parents,

5. Children with neurodevelopment delay,

6. Cognitive impairment, hearing impairment or a visual impairment,

7. Taking an analgesic within 6 hours, or for those with a syncope history.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

Sherzad Khudeida Suleman

Principal Investigator (PhD Student)

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Hockenberry, M. J., & Wilson, D. (2018). Wong's nursing care of infants and children-E-book. Elsevier Health Sciences.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23199786 (View on PubMed)

Mutlu 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.

Reference Type: BACKGROUND

PMID: 25817062 (View on PubMed)

Hendry 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.

Reference Type: BACKGROUND

PMID: 22089042 (View on PubMed)

Rogers 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.

Reference Type: BACKGROUND

PMID: 14963868 (View on PubMed)

Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif. 2006 Jan;30(1):24-49. doi: 10.1177/0145445505282438.

Reference Type: BACKGROUND

PMID: 16330518 (View on PubMed)

Friedrichsdorf 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.

Reference Type: BACKGROUND

PMID: 30324169 (View on PubMed)

Shomaker 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.

Reference Type: BACKGROUND

PMID: 26136310 (View on PubMed)

Uman 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.

Reference Type: BACKGROUND

PMID: 18387963 (View on PubMed)

Other Identifiers

Sherzad

Identifier Type: -

Identifier Source: org_study_id