The Effect of Two Different Methods Applied During Intramuscular Injection on the Level of Pain and Fear in Children

Sponsor
Selmin Kose (Other)
Overall Status
Recruiting
CT.gov ID
NCT05833854
Collaborator
(none)
75
1
3
2.4
31.3

Study Details

Study Description

Brief Summary

This study was planned to determine the effects of using virtual reality glasses and manual pressure during intramuscular injection on the level of pain and fear in children. The study will consist of children aged 6-10 years who come to the Pediatric Emergency Service injection room for prescription penicillin injection and meet the inclusion criteria. One of the main purposes of nursing care is to relieve the child's pain and improve the quality of life. In this context, it has been suggested that two different methods used by the researcher can positively affect the levels of pain and fear. For this reason, it is aimed to determine the efficiency level of two different methods.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality glasses group
  • Other: Manual pressure group
N/A

Detailed Description

75 children and parents meeting the inclusion criteria will be included in the study. For the penicillin injection prescribed by the doctor, the child and the parent who come to the pediatric emergency injection room of the hospital where the research is carried out are informed about the study and the parent is asked to sign the "Informed Consent Form". . After obtaining the consent of the family, the "Child-Parent Information Form" is filled by the researcher through the parent. Simple randomization will be done to give an equal number of samples to the control, virtual reality glasses and manual pressure group to be applied to the child who will participate in the study. Randomization of the study will be done with the online program at the URL https://www.randomizer.org/. Children to be included in the sample will be divided into three groups by randomization method. The numbers from 1 to 75 will be entered into the program without repeating, in order to determine which group the children included in the study will be in. The children who will form the study group through the program will be randomly distributed into 3 groups. . The two interventions in the study will be virtual reality glasses (n=25) and manual pressure (n=25) and control group (n=25).

In the control group (n=25), the child, the parent and the researcher will evaluate the children's fear levels before the procedure with the Child Fear Scale. In this group, a routine intramuscular injection will be made into the vastus lateralis muscle and the researcher will perform the application. No intervention other than routine will be applied. After the intramuscular injection, the pain level of the children will be evaluated by the child, the parent and the researcher with the Facial Expressions Pain Scale-Remodeled.

The group (n=25) wearing VR Glasses will be shown an age-appropriate VR video alongside the routine practice. Before the procedure, the level of fear will be evaluated as in the control group. A virtual reality VR video is watched 1 minute before the intramuscular injection. The child who continues to watch the video is placed on his back and penicillin is injected intramuscularly into the vastus lateralis muscle. Post-injection pain level will be evaluated as in the control group. Virtual reality glasses compatible with "VR BOX 3D" smartphones will be used in this group. Product weight: 0.414 kg. Product size (length x depth x height): 19.5 x 14 x 11 cm/ 7.66 x x5.50 x 4.32 inches. No power adapter or connection cable other than the phone will be needed during use. All children participating in the research will watch the "Hidden Underwater World", which is recommended by taking the opinion of an expert (child developmentist) suitable for their age. The virtual reality glasses used in the application will be disinfected and ready for the next application.

The manual pressure group (n=25) will be evaluated with the Child Fear Scale before the procedure. In addition to the routine application, pressure will be applied to the area to be injected for 10 seconds before the injection process. Pressing with the thumb of the hand, which will be passive in the pressing application, will be understood by the whitening of the nail, and thus pressure will be applied to the skin. Then, as in other groups, an injection will be made into the vastus lateralis area. After the injection, the child will be evaluated in terms of pain with the Facial Expressions Pain Scale revised by the parent and the researcher.

Informed Consent Form, Child-Parent Information Form, Child Fear Scale and Facial Expressions Pain Scale-Revised will be filled for each child who will participate in the study. It is planned to fill the Child Fear Scale before the injection and the Facial Expressions Pain Scale-Revised after the injection.

It is planned that the scales to be applied to the child and parent who will participate in the research will be applied face to face in the injection room of the hospital and 10-15 minutes will be given for each application.

The obtained data will be evaluated using the necessary statistical tests in the computer environment. Evaluation methods will be chosen based on whether the data is homogeneously distributed. If it has a homogeneous distribution, parametric tests will be used. If it does not have a homogeneous distribution, non-parametric methods will be used.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Use of Virtual Reality Glasses and Manual Pressure Method on the Level of Pain and Fear in Children During Intramuscular Injection
Actual Study Start Date :
Apr 18, 2023
Anticipated Primary Completion Date :
Jun 10, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual reality glasses group

The study group (n=25) will watch a video with virtual reality glasses during the intramuscular injection.

Other: Virtual reality glasses group
It is suggested that the use of virtual reality glasses during the injection will positively affect the pain and fear levels in children who received penicillin injection in the pediatric emergency department where the study was conducted.

Experimental: Manual pressure group

In the study group (n=25), pressure will be applied to the area to be injected for 10 seconds before the intramuscular injection procedure.

Other: Manual pressure group
In the pediatric emergency department where the study was conducted, pressure will be applied to the area to be injected for 10 seconds before the injection procedure in children who received penicillin injection. Pressing with the thumb of the hand, which will be passive in the pressing application, will be understood by the whitening of the nail, and thus pressure will be applied to the skin. It is suggested that it can positively affect pain and fear levels.

No Intervention: Control group

The control group (n=25) will not be subjected to any application other than intramuscular injection, which is routinely applied in pediatric emergency.

Outcome Measures

Primary Outcome Measures

  1. Child Fear Scale [The child's fear level will be evaluated by 3 people (child, parent and researcher) 2 minutes before intramuscular penicillin injection is given to the whole group. This process will take 1 minute.]

    The purpose of the Child Fear Scale is to evaluate the fear level of children. It consisted of five facial expressions ranging from neutral expression (0 = No anxiety) to fearful expression (4 = Severe anxiety).

Secondary Outcome Measures

  1. Facial Expressions Pain Scale-Revised [Two minutes after intramuscular penicillin injection is given to the whole group, the child's pain will be evaluated by 3 people (child, parent and researcher). This process takes 1 minute.]

    It is a valid and reliable scale that children can express themselves in their painful situations. It consists of 6 facial expressions that determine the severity and presence of pain by scoring between 0 and 10.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Having applied to the pediatric emergency service for the administration of a penicillin antibiotic group drug,

  • Absence of a significant chronic disease,

  • Absence of visual and auditory disabilities,

  • Having no communication problems and being conscious,

  • No previous history of fainting during injection,

  • Not taking analgesics in the last three hours,

  • Percentile value is in the range of 3-97 points,

  • Injection into the vastus lateralis muscle can be applied,

  • The child's and parent's willingness to participate in the research.

Exclusion Criteria:
  • The percentile value is below 3 and the percentile value is above 97,

  • Family's inability to cooperate in the assessment of pain and fear,

  • Having a diagnosed physical or mental disability,

  • To have taken analgesics in the last 3 hours,

  • Presence of incision and scar tissue in the area to be injected,

  • The child's and parent's refusal to participate in the research.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Selmin Köse Istanbul Turkey 34010

Sponsors and Collaborators

  • Selmin Kose

Investigators

  • Principal Investigator: EMINE KURTAR, RN, HASEKİ EDUCATION AND RESEARCH HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Selmin Kose, Associate Professor Doctor, Biruni University
ClinicalTrials.gov Identifier:
NCT05833854
Other Study ID Numbers:
  • 732202
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Selmin Kose, Associate Professor Doctor, Biruni University

Study Results

No Results Posted as of Apr 27, 2023