Comparison of the Effect of Two Different Interventions (PIK)

Sakarya University

Status: Completed

Conditions: To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous Catheterization

Treatments: Device: Palm Stimulator; Other: Cartoon

Study type: Interventional

Funder types: Other

Identifiers

NCT06772259

E-16214662-050.01.04-236416-36

Details and patient eligibility

About

The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years.

Hypotheses:

H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group.

H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group.

H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group.

H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group.

H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group.

H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group.

H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group.

H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group.

H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group.

H10: PIK application time is different in the palm stimulator group compared to the control group.

H11: PIK application time is different in the cartoon group compared to the co

Full description

1. To measure the pain and fear levels of children by placing a palm stimulator on their palms during PIK application
2. Measuring pain and fear levels by watching cartoons to children during PIK application

Enrollment: 90 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntary participation in the study,
2. Pediatric patients for whom written and verbal consent has been obtained from the parent,
3. Pediatric patients for whom verbal consent was obtained,

(3) Not under the influence of sedative/anticonvulsant/analgesic drugs, (4) Pediatric patients aged 5-12 years, (5) Pediatric patients who can communicate, understand, and carry out commands and are not dependent on technological devices.

Exclusion criteria

1. Not volunteering to participate in the study,
2. More than one PIK attempt,
3. Children with a chronic, acute, or life-threatening illness.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Palm stimulator group

Experimental group

Description:

The Palm Stimulator is grasped in the palm during painful interventions and provides stimulation. Blunt protrusions around the apparatus provide tactile stimulation in the palm. The blunt protrusions have been found to reduce the pain perceived during the intervention by closing the pain gate in the spinal cortex by creating stimuli according to the gate control pain theory without penetrating the skin. The researchers who developed the apparatus were contacted via e-mail and permission was obtained for using the palm stimulator. In the study, the child held the palm stimulator in the palm during the PIK procedure, and the researcher evaluated pain and fear. After the PIK procedure was completed, the child was asked to release the apparatus from the palm.

Treatment:

Device: Palm Stimulator

Cartoon group

Experimental group

Description:

Distraction by watching cartoons is a promising, cost-effective, and non-pharmacologic technique to reduce pain in children undergoing painful procedures. The cartoon was selected by expert researchers from the pediatric field in the research team following the age and consciousness level of the children. A projection device was placed in the intervention room for data collection. The cartoon was projected on a blank wall in the intervention room. The cartoon was played in preparation for the PIK procedure, and children were allowed to watch it until it was completed.

Treatment:

Other: Cartoon

Control gruup

No Intervention group

Description:

In the control group, the routine application phase was performed. Age-appropriate children were seated in the blood sampling chair, and those who could not sit were placed on a stretcher, and PIK was performed. The parent was also taken to the intervention room during the procedure.