Determining the effect of Stroke Back Massage on the anxiety and physiological index of diabetic mothers admitted to Beasat hospital in Sanandaj, 2019
Design
Clinical trials with control group, available sampling and randomized sampling using the Pack envelopes containing letters A and B
Settings and conduct
This study will be carried out in the high risk mothers section of Beasat Hospital in Sanandaj.
Intervention in people who entered the intervention group, will be in such a way that for 4 consecutive days each day for 10 minutes at 6-4 pm in a room that has the usual conditions of massage, including dim light, a relaxed place and a suitable chair Will be given massage by the researcher.
During the study, patients in the control group will not undergo any other intervention except for the usual treatments.
Participants/Inclusion and exclusion criteria
Mothers with gestational diabetes mellitus with a mild to severe anxiety score (20 and above) based on the Spielberger anxiety inventory
Intervention groups
Intervention group: The diabetic mothers are admitted to the high-risk department of Besat Hospital in Sanandaj, which in addition to receiving usual care during admission, for 4 days, receive 10 minutes a day stroke back massage .
Control group: The diabetic mothers admitted to the high-risk department of Besat Hospital in Sanandaj, which received routine care during admission and will not receive any massage.
Main outcome variables
Anxiety; Physiological index including heart rate, blood pressure, respiratory rate, body temperature, blood Sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190122042464N1
Registration date:2019-04-06, 1398/01/17
Registration timing:registered_while_recruiting
Last update:2019-04-06, 1398/01/17
Update count:0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
trefa mehri
Name of organization / entity
Medical university of kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 44 4433 0566
Email address
mehri.t@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Stroke Back Massage on the anxiety and physiological index of diabetic mothers admitted
Public title
The effect of Stroke Back Massage on the anxiety and physiological index of diabetic mothers admitted
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Second and third trimester of pregnancy
The second day of hospitalization
Women with gestational diabetes
Exclusion criteria:
history of spinal cord injury or surgery
Any skin and bone disorders in the neck, back and sacrum
High-risk pregnancies such as multiple pregnancies
Heart disease, kidney disease, asthma and depression
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Randomization: Using a packet containing letters A and B.
The units were randomly assigned to the packets containing letters A and B in one of the groups of intervention group (A) or control (B) using a simple envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee medical university of kurdistan
Street address
Pasdaran Boulevard, Medical University of Kurdistan
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2019-01-18, 1397/10/28
Ethics committee reference number
IR.MUK.REC.1397.312
Health conditions studied
1
Description of health condition studied
Gestational diabet, anxiety, stroke back massage
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of anxiety in diabetic pregnant Women in the Spielberger Questionnaire
Timepoint
Before the intervention, the fourth day of the intervention, 2 and 4 days after the end of the intervention
Method of measurement
Spielberger Anxiety Inventory
2
Description
Blood pressure
Timepoint
Days 1,2,3,4 interventions before and after intervention then 2 and 4 days after intervention
Method of measurement
Using a pressure gauge
3
Description
Heart beat
Timepoint
Days 1,2,3,4 interventions before and after intervention then 2 and 4 days after intervention
Method of measurement
Using the clock, the number is counted in a minute by the researcher
4
Description
Number of breaths
Timepoint
Days 1,2,3,4 interventions before and after intervention then 2 and 4 days after intervention
Method of measurement
Using the clock, the number is counted in a minute by the researcher
5
Description
Body temperature
Timepoint
Days 1,2,3,4 interventions before and after intervention then 2 and 4 days after intervention
Method of measurement
Using a thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Diabetic mothers are admitted to the high risk department of Besat Hospital in Sanandaj, who receive regular care for 4 days at the time of admission and receive 10 minutes a day for back stroke massage every day.
Category
Other
2
Description
Control group: Diabetic mothers are admitted to the high-risk section of Besat Hospital in Sanandaj, who receive routine care during admission and do not receive any massage.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat hospital
Full name of responsible person
trefa mehri
Street address
Keshavarz Street, Meroux Crossroads
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3328 5910
Email
besathospital@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Farzin Rezaee
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 6633 5346
Email
f.rezaee@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Trefa Mehri
Position
Midwifery Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
KurdistanUniversity of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
trefa.mehri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak SHahoie
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4653
Email
rshaho@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Trefa Mehri
Position
Midwifery Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kurdistan University of Medical Sciences, Pasdaran Blv
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
trefa.mehri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD