Evaluating the effectiveness of stress ball for the management of botulinum toxin injection pain in volunteers receiving Botox to eliminate hyperkinetic facial wrinkles on the upper face: a randomized self-controlled trial
The aim of the present study is to investigate whether the stress ball can reduce pain during BT injection.
Design
Before injection on one side, two stress balls are placed in both palms. Patients are asked to "squeeze the stress balls twice and count to five" and "repeat this until the end of the entire injection". Stress balls have medium hardness and are made of high quality silicone. At the same time as squeezing the stress balls, BT injection is also done. Immediately after BT injection, patients complete questionnaires that indicate the level of pain experienced. Then it is injected to the opposite side with out using the balls and the questionnaire is completed again. In half of the patients, the intervention is performed in the first injection (right side) and in the rest in the second injection (left side).
Settings and conduct
This study is conducted in dermatology clinic by the dermatologist of the team and on volunteers who come to the clinic for Botox injections.
Participants/Inclusion and exclusion criteria
(1) age above 18 years (2) Volunteers wants to correct hyperkinetic facial wrinkles through Botox injection in the upper face.
Intervention groups
To perform this investigation, patients must squeeze two stress balls in their hand during Botox injection on one side of the face.
Main outcome variables
Visual Analog Scale (VAS) questionnaire will be used to measure the pain caused by the injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059230N1
Registration date:2023-09-22, 1402/06/31
Registration timing:registered_while_recruiting
Last update:2023-09-22, 1402/06/31
Update count:0
Registration date
2023-09-22, 1402/06/31
Registrant information
Name
Bahareh ٍebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 2202
Email address
ebrahimi_b@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of stress ball for the management of botulinum toxin injection pain in volunteers receiving Botox to eliminate hyperkinetic facial wrinkles on the upper face: a randomized self-controlled trial
Public title
Evaluating the effectiveness of the stress ball for the management of botulinum toxin injection pain: a randomized controlled trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years.
Volunteering to correct hyperkinetic facial wrinkles by intramuscular injection of Botox in the upper face, including forehead, lateral orbital, and glabellar.
Exclusion criteria:
No history of allergy to Botox
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The "intervention" is performed in half of the patients while injecting on the right side, and in the rest while the left side is being injected. To randomly select the intervention half, we write the words "right" and "left" on some cards and ask the patient to choose a card.
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 Committee, Faculty of Medicine, Shiraz University of Medical Sciences
Street address
School of Medicine, Imam Hossein square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Approval date
2022-07-16, 1401/04/25
Ethics committee reference number
IR.SUMS.MED.REC.1401.201
Health conditions studied
1
Description of health condition studied
Skin Wrinkle
ICD-10 code
L98.9
ICD-10 code description
Disorder of the skin and subcutaneous tissue, unspecified
Primary outcomes
1
Description
Injection pain
Timepoint
Immediately after injection
Method of measurement
Visual Analog Scale (VAS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: participants were asked to squeeze stress balls in both hands during the BT injection (on one side of the face).
Category
Treatment - Devices
2
Description
Control group: the group that does nothing during BT injection (on one side of the face).