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Investigating the effect of the magic glove technique on the pain and anxiety of children during Leupromer injection

Protocol summary

Study aim
Investigating the effect of the magic glove technique on the pain and anxiety of children during Leupromer injection
Design
A clinical trial with a control and intervention group, with parallel groups, examining the results in 60 children, blinding is not done, the block randomization method will be used. Available sampling and random allocation using the quadruple block method (through the randomization site)
Settings and conduct
The samples are randomly distributed into two control and intervention groups. Data collection is done before and after the injection. In the intervention group, the magic glove is performed and then the injection is performed, but in the control group without intervention, only the injection is performed.
Participants/Inclusion and exclusion criteria
Entry requirements: have mental health and alertness, be healthy in terms of hearing, have no pain due to illness, have experience with lopromer injection (1 or more injections have been done for them). Conditions of non-entry: receipt of sedative, painkiller or anti-anxiety medication, any life-threatening emergency, a score greater than 5 in reducing the child's pain in the desensitization stage of the magic glove technique
Intervention groups
In the intervention group, the magic glove technique will be performed before the injection of lopromer, but in the control group, only drug injection will be performed. Before the intervention, demographic information and anxiety measurement will be done in both groups, and after the injection, pain and anxiety measurement and comparison will be done in both groups.
Main outcome variables
Pain and anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240111060681N1
Registration date: 2024-01-22, 1402/11/02
Registration timing: prospective

Last update: 2024-01-22, 1402/11/02
Update count: 0
Registration date
2024-01-22, 1402/11/02
Registrant information
Name
Faezeh Rostamian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3333 1788
Email address
faezeh78rostamian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the magic glove technique on the pain and anxiety of children during Leupromer injection
Public title
Investigating the effect of the magic glove technique on the pain and anxiety of children during Leupromer injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having mental health and alertness Being healthy in terms of hearing No pain caused by the disease Have the experience of Leupromer injection (1 or more injections have been done for them). Boys and girls 3-12 years old
Exclusion criteria:
Receiving a sedative, pain reliever or anti-anxiety medication Any life-threatening emergency A score greater than 5 in reducing the child's pain in the desensitization stage of the magic glove technique
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To assign the target group to one of the two study groups; The intervention group and the control group (group A and group B) will use the block randomization method with blocks of four. Then, the participants will be assigned to one of the two groups 1: magic glove, 2: no intervention according to the block randomization protocol (produced by Random Allocation Software) with a ratio of 1:1, In such a way, the researcher cannot predict which group of intervention the next person will be placed in. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Tehran University of Medical Sciences Central Building, intersection of Qods St.,Keshavarz Boulevard
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-12-16, 1402/09/25
Ethics committee reference number
IR.TUMS.FNM.REC.1402.181

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F93.1
ICD-10 code description
Phobic anxiety disorder of childhood

2

Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
Child anxiety
Timepoint
Before the start of the intervention and after the end of the injection.
Method of measurement
A revised anxiety behavioral observational instrument

2

Description
Child's pain
Timepoint
After the end of the injection
Method of measurement
Wong Baker Tool

Secondary outcomes

empty

Intervention groups

1

Description
.According to the Rel@x manual published by Aramideh et al., the magic glove technique consists of 4 steps. Step 1: Introducing the magic glove to the child "I have a magic glove to protect your arm well. Do you agree that Shall I explain to you why it is magical?" The nurse explains to the patient that the magic glove will help him change the sensations in his arm. It's important to avoid saying, "You won't feel any pain," as negative suggestions can lead to stress. Then, the nurse asks the patient to put his hand or arm in hers and suggests, "Relax in my hand." By feeling the full weight of the arm in his hand, the nurse makes sure that the patient has released his arm. The second step (applying the magic glove): The nurse asks the patient: "What kind of magic glove would you like to have? Can you Describe it to me?" He allows the patient's creativity to do this imaginative work. Then, the nurse pretends to take the magic glove described by the patient out of her pocket and place it on the patient's hand.He starts with the patient's fingers and then uses the palm of his other hand to gently stroke them up to the wrist or cubital area. The nurse ensures that the end of the glove is clearly marked with each stroke and for each finger. She performs these strokes several times while continuously talking to the child so that the patient can imagine the glove on his arm. Third stage (Desensitization): The nurse confirms the patient's sensory attention by talking about the process while putting on the magic glove. he does. "This glove protects you so you're aware of what's going on. It won't hurt you. While you're wearing the glove, you'll feel changes happening.Your arm is protected, it feels like you're going to be well protected from anything... Do you feel how protected your hand is?” The nurse repeats the same words over and over while applying the magic glove. At the end of the last stroke, the nurse gently squeezes the upper arm and says, "Here, the magic glove is in place. Now that you have your magic glove, you'll find that you won't be bothered anymore. It is going very well. It will be convenient."In this case, the nurse tests the glove to see how well this technique protects the patient. First, the nurse presses the back of the hand untouched by the magic glove 3 times with a sharp pencil and says : "This is a perfect sensation because there is no magic glove, so the score is 10 out of 10." He tests the hand with the magic glove by applying equal pressure. He asks the patient to rate the sensation out of 10. Score 5 or less is great.Now that the magic glove is in place, the nurse can administer the injection. Here, if necessary, the nurse adds another focus by asking the patient to talk about the magic glove and describe it. During the injection, he reminds the patient: "Notice how this glove protects you!" He continues to stroke the arm to adjust the glove if necessary.The fourth stage (end of treatment): After the injection, the nurse removes the magic glove. He does this by stroking the arm in the opposite direction to make sure full sensation has returned to the patient's hand. He asks the patient to rub his hands as if he were washing them to normalize his feelings. This should be continued until the patient confirms that sensation has returned
Category
Behavior

2

Description
Control group: Without intervention, only injection is done.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir al-Momenin Hospital, Semnan city
Full name of responsible person
Sati Nickdarzi
Street address
Plate No. 9771, Shahid Mostafa Khomeini Boulevard, Imam Hussein Square.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Fax
+98 23 3346 1580
Email
amir.hospital@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Assistant, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbari Sari
Street address
Tehran University of Medical Sciences Central Building, intersection of Qods St.,Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faezeh Rostamian
Position
Master Students in Pediatric Nursing, School of Nursing & Midwifery, Tehran University of Medical Sc
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St, Tawheed Square
City
تهران
Province
Semnan
Postal code
3565416546
Phone
+98 21 6692 7171
Email
faezeh78rostamian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faezeh Rostamian
Position
Master Students in Pediatric Nursing, School of Nursing & Midwifery, Tehran University of Medical Sc
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St, Tawheed Square
City
Tehran
Province
Tehran
Postal code
3565416546
Phone
+98 21 6692 7171
Email
faezeh78rostamian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faezeh Rostamian
Position
Master Students in Pediatric Nursing, School of Nursing & Midwifery, Tehran University of Medical Sc
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St, Tawheed Square
City
Tehran
Province
Tehran
Postal code
3565416546
Phone
+98 21 6692 7171
Email
faezeh78rostamian@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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