The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy

NCT ID: NCT04513873

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-18
• Study Completion Date: 2019-03-28

Brief Summary

This study aimed to investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=127) and the control group (n=129). The control group was applied to standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment that looks like a blood tube in front of them during the phlebotomy process to divert their attention from the phlebotomy process to the equipment.

Detailed Description

The equipment used for the intervention group was designed and developed by the researchers with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a blood tube with a fixed arm on the right and a moving arm on the left with a total height of 80 cm. It has some answers to common questions of parents as well as the key concerns of the children " Will it hurt me?"

Conditions

Pain and Anxiety of Children During Phlebotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Equipment Intervention Group

The intervention group had equipment that looks like a blood tube in front of them during the blood collection process to divert their attention from the blood collection process to the equipment. This equipment was with a fixed arm on the right and a moving arm on the left with a total height of 80 cm as well as a red light-emitting diode(LED) to stimulate the blood collection. It had some answers to common questions of parents as well as the key concerns of the children like " Will it hurt me?". The equipment was made a musical device by loading the most popular children's songs into its database.

Group Type: EXPERIMENTAL

Equipment to divert the focus of children

Intervention Type: DEVICE

The equipment was placed in an area where the children would be able to see easily during the blood collection process. It was turned on as soon as the children sat on to the chair where the process would take place to divert the focus of the children at the equipment.

No Intervention Group

Standard blood collection procedures were applied to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Equipment to divert the focus of children

The equipment was placed in an area where the children would be able to see easily during the blood collection process. It was turned on as soon as the children sat on to the chair where the process would take place to divert the focus of the children at the equipment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• making a request for the phlebotomy
• being in the 7-12 age group
• having the consent of the parent
• willing to participate in the research
• with the history of invasive procedure
• not using any medication with analgesic effect in the last 12 hours
• without any communication barriers of either child or the parent
• with a normal level of consciousness during the process
• without the history of passing out during the phlebotomy

Exclusion Criteria

• not being in the 7-12 age group
• not having the consent of the parent
• not willing to participate in the research
• without the history of invasive procedure
• had medication with analgesic effect in the last 12 hours
• with communication barriers of either child or the parent
• with an abnormal level of consciousness during the process
• with the history of passing out during the phlebotomy

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Yeliz Ciğerci

Assistant Professor PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Manavgat State Hospital

Antalya, Manavgat, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019/37

Identifier Type: -

Identifier Source: org_study_id