Venous Blood Sampling-Related Pain and Fear

NCT03720808 | Completed DMC

• 1 other identifier: SY200217B06
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an experimental randomized controlled study conducted to compare the effect of balloon blowing, coughing, and ball squeezing methods applied during venous blood sampling from on pain and fear level in 7-12 year-old children. The population of the study consisted of all 7-12 year-old children who were referred to the blood-letting room for venous blood sampling in a state hospital. The sample of the study was determined as 120 children with confidence level of 95% and theoretical power of 95%. The children were divided into 4 groups of 30 people, including balloon blowing, ball squeezing, coughing, and control groups. Each intervention and control group was matched in terms of gender. In the study, the randomization of the sample group was performed by using stratification and block randomization methods.

Conditions

Pain; Fear

Keywords

pain management; pain in children; venous blood sample; non-pharmacological method

Outcome Measures

Primary Outcomes (1)

• Pain severity

  The children and the parents were informed about the Wong Baker Faces Pain Rating Scale and they were asked to mark the children's pain levels on the scale 5 minutes before and after the venipuncture procedure. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales. Wong Baker Faces Pain Rating Scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. The scale is one of the commonly used scales for measuring pain severity in children aged between 3-18 years. This scale has the faces and the pain score is determined according to the numerical values given to the faces. While smiley face "0 point" shows lack of pain, crying face "10 points" refer to severe pain.

  5 MONTHS

Secondary Outcomes (1)

• Fear levels

  5 MONTHS

Study Arms (4)

Balloon Blowing

EXPERIMENTAL

Venous blood sampling started as the children exhaled to blow up the balloon. Until the venous blood procedure ended, they continued to blow up the balloons.

Other: Balloon Blowing

Ball Squeezing

EXPERIMENTAL

Before the venous blood collecting procedure, a soft ball was given to the right hands of the children and they were asked to squeeze and release this ball during the procedure.

Other: Ball Squeezing

Coughing

EXPERIMENTAL

Just before the entrance of the needle, the child was asked to take a deep breath and the venous blood sampling procedure was started during coughing.

Other: Coughing

Control

EXPERIMENTAL

No intervention was performed to reduce pain and fear in the control group.

Other: Control

Interventions

Balloon Blowing OTHER

The parents of the children in this group were asked whether their children had the latex allergy or not and the children without the allergy were included in the group. The children's skills of blowing balloon were observed before the procedure. Before starting the venous blood sampling procedure, the children were asked to choose a balloon in the color they preferred and to start blowing the balloon at least 20 seconds before the procedure. Venous blood sampling started as the children exhaled to blow up the balloon. Until the venous blood procedure ended, they continued to blow up the balloons.

Balloon Blowing

Ball Squeezing OTHER

Before the venous blood collecting procedure, a soft ball was given to the right hands of the children and they were asked to squeeze and release this ball during the procedure.

Ball Squeezing

Coughing OTHER

The children included in this group were asked to cough after taking a deep breath during the venous blood sampling procedure. Before the procedure, the researcher showed the children how they should cough and asked them to imitate. The venous blood sampling was not performed until the child successfully completed coughing. The child was directed by the researcher during the procedure. Just before the entrance of the needle, the child was asked to take a deep breath and the venous blood sampling procedure was started during coughing.

Coughing

Control OTHER

No intervention was performed to reduce pain and fear in the control group.

Control

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The children,
• who were aged between 7-12 years,
• were healthy,
• did not receive any analgesic within the last 6 hours before venipuncture procedure,
• had no history of syncope during venipuncture procedure,
• agreed to participate in the study and gave the verbal and written consent.
• be healthy in terms of neurological functions,
• communicate verbally,
• understand and read Turkish,
• voluntarily sign the written informed consent.

You may not qualify if:

• The children;
• who had neuro-developmental disorder,
• could not communicate verbally,
• had hearing and visual impairment,
• suffered from acute pyretic disease,
• received topical anesthesia, took any analgesic within the last 6 hours before venipuncture procedure,
• had chronic disease requiring frequent venipuncture.

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Çankırı Karatekin Univesity

Çankiri, 18200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Burcu AYKANAT GİRGİN, PhD.RN

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD RN, Asistant PROFESSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: March 1, 2017
• Primary Completion: July 20, 2017
• Study Completion: November 15, 2017
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

TU (1)