The effect of counseling with hope therapy approach on improving perceived stress and quality of life of women suffering from pregnancy nausea and vomiting
The effect of counseling with hope therapy approach on improving quality of life and perceived stress of women suffering from pregnancy nausea and vomiting
Design
The study is a phase 3 of parallel randomized clinical trial, with a control group which will be conducted on 68 patients (34 intervention and 34 control). Women suffering from pregnancy nausea and vomiting will be selected in the convenience sampling method and then will be allocated in two groups with the block random allocation method with a block size of 4. Random blocks will be selected from the table of random numbers. There is no blinding.
Settings and conduct
The setting of study includes the all comprehensive health centers of Zanjan city and the research population includes all pregnant women suffering from pregnancy nausea and vomiting who referring to the mentioned centers. The women will be will be allocated in two groups with the block random allocation method with a block size of 4. There is no blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age of 6 to 12 weeks, obtaining a score of 17-32 from the Rhodes Nausea and Vomiting Questionnaire and a score of 18-36 based on the Cohen Stress Questionnaire.
Exclusion criteria: suffering from chronic diseases, suffering from gastrointestinal disease, depression, taking psychiatric drugs, narcotics and psychotropic drugs, experiencing traumatic and stressful events in the last 3 months, symptoms of miscarriage, presence of molar pregnancy , and ectopic
Intervention groups
The intervention group" Hope therapy counseling will be held in 8 sessions with intervals of twice a week and each session lasts 90 minutes in the comprehensive health centers of Zanjan city.
The control group: the usual prenatal care and adherence to diet will be ordered
Main outcome variables
Quality of life, perceived stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150731023423N22
Registration date:2023-07-11, 1402/04/20
Registration timing:prospective
Last update:2023-07-11, 1402/04/20
Update count:0
Registration date
2023-07-11, 1402/04/20
Registrant information
Name
Azam Maleki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 4264
Email address
malekia@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-01-31, 1402/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with hope therapy approach on improving perceived stress and quality of life of women suffering from pregnancy nausea and vomiting
Public title
The effect of counseling with hope therapy approach on improving perceived stress and quality of life of women suffering from nausea and vomiting of pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestation age 6 to 12 weeks
Low risk pregnancy
Wanted pregnancy
Obtaining a score of 17-32 based on the Rhodes Nausea and Vomiting Questionnaire
Obtaining a score of 18-36 based on Cohen's Perceived Stress Questionnaire
Singleton pregnancy based on ultrasound
Exclusion criteria:
Suffering from chronic diseases
Suffering from depression (getting a score of 12 or more from the Edinburgh Questionnaire)
Suffering from digestive diseases
Taking psychiatric drugs
Drug and psychedelic use
Experiencing traumatic and stressful events in the last 3 months
Symptoms of miscarriage
Presence of molar or ectopic pregnancy
Presence of ectopic pregnancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women will be selected during routine prenatal care and then will be allocated into two intervention ans control groups using the block random allocation method with a block size of 4; For this purpose, blocks of 4 will be selected using a table of random numbers in the size of 17 blocks so that the sample size reaches 68 people. Blocking will be done by a person not involved in sampling. Each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. Finally, the lids of the envelopes will be glued and placed inside a box. At the start of the intervention to identify the order of the participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.
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
Ethics Committee of Zanjan University of Medical Sciences
Street address
Jomhori Eslami Ave, Azadi Square,The first floor of Deputy of research and technology of Zanjan University of Medical sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
IR.ZUMS.REC.1402.080
Health conditions studied
1
Description of health condition studied
Quality of life in women with pregnancy nausea and vomiting
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Perceived Stress
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified
Primary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention, 8 weeks after the end of the intervention
Method of measurement
The Pregnancy Nausea and Vomiting Quality of Life
2
Description
Perceived Stress
Timepoint
Before the intervention, 8 weeks after the end of the intervention
Method of measurement
Cohen's Perceived Stress Questionnaire
Secondary outcomes
1
Description
Hope for Life
Timepoint
Before intervention and 8 weeks after the completion of counseling sessions
Method of measurement
Hope for Life Scale
Intervention groups
1
Description
Intervention group: Hope counselling will be conducted in a group format. It will consist of 8 sessions, held twice a week, with each session lasting 90 minutes at the Comprehensive Health Centers in Zanjan City. The content of the sessions will be designed based on the developed treatment plan by Snyder. In the hope therapy sessions, women will become familiar with concepts such as hope, understanding the growth of hope, and the necessity of hope in life. Individuals will be encouraged to express their life stories, current events, and important dimensions of life. They will prioritize life events based on their importance, set goals for each area of life, develop pathways and appropriate strategies to achieve the set goals and transform these pathways into small steps and motivating pathways. Ultimately, individuals are expected to practice positive thinking in their daily lives.
Category
Prevention
2
Description
Control group: The control group will be received the usual prenatal care and diet.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers in Zanjan city
Full name of responsible person
Mahsa Piri
Street address
All health centers in Zanjan city
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 1433 8300
Email
mahsapiri3226006@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Jomhouri Street, Azadi Boulevard, University Headquarters, 1st floor, Deputy of Research and Technology, Zanjan University of Medical Sciences.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3524 2075
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mahsa Piri
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
0098 024 334206519
Email
mahsapiri3226006@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
اعظم ملکی
Position
Assistant Professor in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jomhouri Street, Azadi Boulevard, University Headquarters, 1st floor, Deputy of Research and Technology, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
0098 3342 24 0651
Email
Malekia@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azam Maleki
Position
Assistant Professor in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jomhouri Street, Azadi Boulevard, University Headquarters, 1st floor, Deputy of Research and Technology, Zanjan University of Medical Sciences.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
0098 3342 24 0651
Email
Malekia@zums.ac.ir
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
The possibility of dissatisfaction of the participants