To investigate the effect of tactile stimulation on creative thinking, memory and motor imagery in 18-30 year-old subjects
Design
single blinded randomized clinical trial with parallel control group of 100 normal subjects.
Settings and conduct
The study was a single-blind clinical trial that participated were blinded to implementation or inactivation of the tactile simulations, because the index finger of all participant were placed on the tactile stimulation device. The subjects were selected from students of Estahban Paramedical School.
Participants/Inclusion and exclusion criteria
1- Right-handed according to Edinburgh's questionnaire
2- normal or corrected visual acuity;
3. Not suffering from psychiatric disorders (bipolar type 1 and schizophrenia);
4. Not suffering from known neurological diseases such as stroke, brain trauma, seizure and mental retardation;
5. Non-use of psychotherapy drugs.
Intervention groups
Intervention group: implementation of tactial stimulation on the right index finger for 30 minutes
Control group: the tactile stimulation device was turned off for 30 minutes.
Main outcome variables
creative thinking; memory; motor imagery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180902040927N2
Registration date:2018-10-07, 1397/07/15
Registration timing:retrospective
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Mahdieh Azin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3131 5072
Email address
m.azin@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-03-18, 1396/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tactile stimulation on creative thinking ,memory and motor imagery in 18-30 year-old subjects
Public title
The effect of tactile stimulation on cognitive functions
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Students of Shiraz University of Medical Sciences
The age range was between 18 and 30 years old
Right-handed according to Edinburgh's questionnaire
normal or corrected visual acuity;
Not suffering from psychiatric disorders (bipolar type 1 and schizophrenia);
Not suffering from known neurological diseases such as stroke, brain trauma, seizure and mental retardation;
Non-use of psychotherapy drugs.
Exclusion criteria:
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization according to table of random numbers with software
Blinding (investigator's opinion)
Single blinded
Blinding description
participants were blind in this study. The tactile stimulation device was attached to the finger of all participants, regardless of the type of group, and the participant was unaware of which group was entered. Also, in all questionnaires and computer programs, only the code was used to make the participants were unaware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of rafsanjan university of medical sciences
Street address
Rafsanjan, Gulf Blvd., Pistachio Street,School of Medicine, Rafsanjan University of Medical Sciences (RUMS)
City
Rafsanjan
Province
Kerman
Postal code
7718175911
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.RUMS.REC.1396.59
Health conditions studied
1
Description of health condition studied
Healthy adults
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
reaction time
Timepoint
Before and after tactile stimulation
Method of measurement
Hand mental rotation task with PSYTASK software
2
Description
response accuracy rate
Timepoint
Before and after tactile stimulation
Method of measurement
Hand mental rotation task with PSYTASK software
3
Description
scores of Remote Association Task
Timepoint
Before and after tactile stimulation
Method of measurement
Remote Association Task questionnaire
4
Description
Originality of divergent thinking
Timepoint
Before and after tactile stimulation
Method of measurement
alternate uses task
5
Description
Fluency of divergent thinking
Timepoint
Before and after tactile stimulation
Method of measurement
alternate uses task
6
Description
Flexibility of divergent thinking
Timepoint
Before and after tactile stimulation
Method of measurement
alternate uses task
7
Description
Elaboration of divergent thinking
Timepoint
Before and after tactile stimulation
Method of measurement
alternate uses task
8
Description
Learning score
Timepoint
Before and after tactile stimulation
Method of measurement
Rey Auditory-Verbal Learning Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 minutes of tactile stimulation of the right index finger in one session was applied. A tactile stimulation device (Kavosh Pars Mahan Sanat Co. Iran), consisting of a control unit and stimulus modules to be connected to the hands, was used. The stimulus module has nine pins (1.5 mm height) and stimulate the right fingertip for 30 minutes (16 Hz) with the aid of a computer control system. When the tactile stimulation device was attached to the participants’ hands in both the sham and tactile stimulation groups, the subjects were not required to focus on stimulation or anything else.
Category
Treatment - Devices
2
Description
Control group: A tactile stimulation device (Kavosh Pars Mahan Sanat Co. Iran) were attached to right index finger but the tactile stimulation device was turned off.