NCT05301088

Brief Summary

Nurses are in the position of primary health care provider in relieving children's pain and fears of bloodletting in the wards where they work. As a result of this study, it is aimed to encourage nurses to apply non-pharmacological interventions during painful medical procedures, to facilitate the provision of necessary and different means of distraction to blood collection services, and to contribute to the development of in-house health policies and the preparation of appropriate clinical guides and to add an innovative perspective.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

March 19, 2022

Last Update Submit

July 28, 2022

Conditions

PainFear

Outcome Measures

Primary Outcomes (2)

  • Wong-Baker Faces Pain Rating Scale

    12 week

  • Child Fear Scale

    12 week

Study Arms (3)

Chocolate Scent

EXPERIMENTAL
Other: Chocolate Scent

Stress Ball

EXPERIMENTAL
Other: Chocolate Scent

Control

NO INTERVENTION

Interventions

Chocolate ScentOTHER

Chocolate Scent:Children in this group will be given chocolate scent sniffing as a non-pharmacological distraction method. Stress Ball:Stress ball squeezing will be used as a non-pharmacological distraction method for children in this group.

Also known as: Stress Ball
Chocolate ScentStress Ball

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age group,
  • children who need blood drawn for any reason
  • have no disease that can cause chronic pain,
  • no olfactory disorder
  • no mental or neurological problems
  • able to communicate
  • speaks Turkish

You may not qualify if:

  • those who did not give consent to the research by both the child and the parent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 29, 2022

Study Start

April 1, 2022

Primary Completion

May 30, 2022

Study Completion

June 30, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Locations

TU(1)