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Examining the Effectiveness of solution-focused brief consulation with emphasis on self-efficacy on stress and depression and anexity of mothers with gestational diabetes under insulin treatment

Protocol summary

Study aim
Examining the Effectiveness of solution-focused brief consulation with emphasis on self-efficacy on stress and depression and anexity of mothers with gestational diabetes under insulin treatment 1.comparison mean score of stress in mothers with gestational diabetes under insulin treatment before and after intervention in intervention group and control group 3.comparison mean score of anexity in mothers with gestational diabetes under insulin treatment before and after intervention in intervention groupand control group 5.comparison mean score of depression in mothers with gestational diabetes under insulin treatment before and after intervention in intervention groupand control group
Design
A randomized, blinded, controlled clinical trial with a parallel group design of 56 patients, enrolled between October 2020 and September 2020, and are followed at 16 week after intervention.
Settings and conduct
Mothers were choosen randomly in kamkar hospital.consulation were given in health center mothers were unaware of planing for others and analizer dont know of intervention and control group
Participants/Inclusion and exclusion criteria
mothers with gestational age at 10-38 week,under insulin treatment,condition that cannot enter:when disaster happens or morbidity related to pregnancy happens or mother absent more than one session
Intervention groups
intervention consist of 6 session of problem solution consultation at 90 minute weekly is done,mothers with gestational diabetes under insulin treatment in control group mothers with gestational diabetes under insulin treatment that take routine prenatal care
Main outcome variables
Mean score of stress in intervention group is lesser than control group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200202046339N1
Registration date: 2020-02-17, 1398/11/28
Registration timing: registered_while_recruiting

Last update: 2020-02-17, 1398/11/28
Update count: 0
Registration date
2020-02-17, 1398/11/28
Registrant information
Name
zahra rafiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3289 6264
Email address
z.rafiei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the Effectiveness of solution-focused brief consulation with emphasis on self-efficacy on stress and depression and anexity of mothers with gestational diabetes under insulin treatment
Public title
Examining the Effectiveness of solution-focused brief consolation on mothers with gestational diabetes under insulin treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers at10-38 week gestational age Mothers Have at least a fifth grade(primary) education non-smoking and no addiction to psychological drug or alcohol,... no history of medical illnesses, such as, cardiovascular diseases, hypertension, epilepsy, migraine, thyroid disease, connective tissue disease, asthma, respiratory disorders, kidney failure, anemia, and stroke, no histotry of hospitalization due to mental illnesses or abuse of psychological drugs under insulin treatment singleton pregnancy
Exclusion criteria:
individuals who were unwilling to continue the research absent more than one session, of 6 consultation sessions. who experienced pregnancy-related complications, including bleeding, hypertension, early delivery, and surgery or hospitalization for current pregnancy, as well as delivery or abortion during the study severe psychiatric disorders or disaster, happened in pregnancy occurrence of major stressful events during the study
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Urn RandomizationUrn method was used to allocate individuals in each study group A research assistant who was not involved in the recruitment of participants prepared the 56 papers, back of 56 paper was written control or intervention group,He mixed it up, provided one of the relevant papers for every one . Participants allocated to the control group (n = 28) received standard care. Participants assigned to the intervention group (n = 28) also received standard care plus solution-focused brief consolation , The intervention consisted of 6 solution-based counseling sessions that were held weekly before the intervention questionnaires were completed by two group .6 weeks and 16 weeks after the intervention, the post test was conducted for both experimental and control groups to evaluate the effect of the intervention after the intervention and 16 weeks after the intervention
Blinding (investigator's opinion)
Double blinded
Blinding description
due to nature of intervention participants and resercher was not blind but Outcome assessors and analyzer were blind
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Naghshe jahan Apt,No. 15, EDALATAvenu, Ensegam street , Qom Town
City
Qom
Province
Ghoum
Postal code
3713436969
Approval date
2019-12-15, 1398/09/24
Ethics committee reference number
ir.arakmu.rec.1398.253

Health conditions studied

1

Description of health condition studied
stress,anexity,depression, in mothers with gdm
ICD-10 code
O24.41
ICD-10 code description
Gestational diabetes mellitus in pregnancy

Primary outcomes

1

Description
stress score in dass21 scale
Timepoint
Before intervention, 6 week and 16 week after intervention
Method of measurement
dass21 scale

2

Description
anexity score in dass21 scale
Timepoint
Before intervention,6 week and 16 week after intervention
Method of measurement
dass21 scale

3

Description
depression score in dass21 scale
Timepoint
Before intervention,6 week and 16 week after intervention
Method of measurement
dass21 scale

4

Description
Behavioral sterategies for coping with steress
Timepoint
Before intervention,6 week and 16 week after intervention
Method of measurement
ciss scale

Secondary outcomes

1

Description
self efficacy
Timepoint
Before intervention,6 week ,16 week after intervention
Method of measurement
Dmses scale

Intervention groups

1

Description
Intervention group: prenatal care + intervention ,Intervention consist of 6session: In the first session, introduction, After that, mothers were provided with the content of Principles of solution-focused brief consultation , the mothers were provided with information about diabetes and help them , identification of the problem, clearly , How does gestational diabetes affect mother and her child?2- In the second session setting the goals of consultation in gdm In this session participants were Helped understand their abilities, participants were educated to understand each other's perspectives, motivating each other, who is at risk for pregnancy complications , creation of alternative solutions, the participants were taught about the effect of the diabet on pregnancy and self-care (nutrition, physical activity, prevention of infection, vaccination, drug, etc.). 3 In the third session,--Change viewpoint and highlight self-efficacy In this session, the participants were taught about the effect of the diabet on pregnancy and self-care (nutrition, physical activity prevention of infection, vaccination, drug, etc assessment of consequences, selection of the solution , how to treat gestational diabetes, diet and exercise in gestational diabetes and self care, daydreaming.). Principles of self-care- 4In the forth session- use of Practical Techniques in problem solving and the Nutritionist's Guide and exercise and treatment In Gestational Diabetes were taught, the interventionist emphasized understanding one’s own thoughts and feelings and modifying self-dialogue towards more positive messaging. Therefore, the patients were taught to reflect on their thinking and respond to situations, solved the problems, and used their thoughts to help follow through with the decision they made previously, and evaluation of the outcomes Using a miracle question by a consultant And consulting with the person who understands the good and the bad moments is the result of his thoughts and behavior , Blood glucose monitoring, use of Glucometer, Assignment . 5In fifth session,Use Principles of problem solving consultation (miracle and scale questions) and monitor blood sugar Pregnancy with normal gestational diabetes, Relaxation,normal delivery or c/section in gdm , 6-In the last session( final) the interventionist summarizing the content and emphasize postpartum blood glucose monitor, the intervention were evaluated. Moreover, the interventionist answered the mothers’ questions Use the word instead to experience new emotions Highlighting responses to postpartum maternal hyperglycemia, relaxation,
Category
Lifestyle

2

Description
Control group:just take routinize prenatal care
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
kamkar Hospital
Full name of responsible person
Rafiee Zahra
Street address
Apt Naqshe Gahan, No 15Edalat , Ensejam, Qom
City
Qom
Province
Ghoum
Postal code
3713436969
Phone
+98 25 3289 6264
Email
z.rafiei@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Kamali Alireza ,Deputy OF Technology Research of Arak Medical university
Street address
Arak University Of Medical Scienes, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-7-6941
Phone
+98 86 3417 3638
Fax
Email
amoozesh@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Rafiee Zahra
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Apt Naqshe Gahan,No15 Edalat,Ensegam,QOM
City
Qom
Province
Ghoum
Postal code
3713436969
Phone
+98 25 3289 6264
Email
Zrfyy475@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vakilian Katayon
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medical University, Basij Squre, Arak
City
Arak
Province
Markazi
Postal code
38481-7-6941
Phone
+908634173638
Email
cattyv2002@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Rafiee Zahra
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Apt Naqshe Gahan, No15 Edalat, Ensegam, Qom
City
QOM
Province
Ghoum
Postal code
3713436969
Phone
+98 25 3289 6264
Email
z.rafiei@arakmu.ac.ir

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
No - There is not 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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