Protocol summary
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Study aim
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The Effect of Counseling Using Positive Approach on Maternal Adaptation and Severity of Pregnancy Nausea and Vomiting
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Design
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The Present Study Is Phase 3 Of A Randomized Clinical Trial, Has A Control Group With Parallel Groups. That Will Be Performed On 60 Patients (30 Interventions And 30 Control Interventions). We Do Not Have Blinding. Eligible Women Will Be Selected By Convenience Sampling Method And Will Be Assigned To Two Intervention And Control Groups Using 4 Random Blocks.
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Settings and conduct
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The Study Population Includes Women with Nausea and Vomiting That Will be Selected Using the convenience Sampling Method and then Randomly Assigned to the Intervention and Control Groups by the 4 Block Design.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Having 3-16 Scores Based on the Reduz Pregnancy Nausea and Vomiting Questionnaire, Gestational Age 6-10 Weeks, Age 18-35 Years, Wanted Pregnancy, Normal Pregnancy and Access to Telephone.
Exclusion criteria: Having High-Risk Pregnancy Symptoms, Stressful Events, Unwillingness to Continue Participating in The Study.
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Intervention groups
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The Intervention Group Six Sessions of Individual Positive Counseling Based on The Silgman Protocol (2006) Will be Done With Emphasizing the three Paths to Happiness (Enjoyment, Commitment, and Meaning in Life). Each Session Will be Done 45 Minutes in 3 Times a Week.
The Control Group will Receive Routine Care.
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Main outcome variables
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Coping and Severity of Nausea and Vomiting in Pregnancy
General information
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Reason for update
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Changing the start time of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150731023423N17
Registration date:
2020-10-31, 1399/08/10
Registration timing:
prospective
Last update:
2020-11-02, 1399/08/12
Update count:
1
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Registration date
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2020-10-31, 1399/08/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-01, 1399/08/11
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Expected recruitment end date
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2021-02-23, 1399/12/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effec of Consultation Using Positive Approach on Maternal Adaptation and Severity of Pregnancy of Nausea and Vomiting
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Public title
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"The Effec of Consultation Using Positive Approach on Maternal Adaptation and Severity of Pregnancy of Nausea and Vomiting"
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having 3-16 Scores Based on RHODES' Pregnancy Nausea and Vomiting Questionnaire
Gestational Age 6-10 Weeks
Wanted Pregnancy
Phone Access
Normal Pregnancy
The Lack of Chronic Disease
The lack of Psychological disease
Exclusion criteria:
Having of High-risk Pregnancy Symptoms
Occurrence of Severe Stressful Events Such as Divorce or Death of Loved Ones
Not Desire to Continue to Participate in The Study
More Than Two Absence in Counseling Sessions
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible Women Will be Selected Using the Convenience Sampling Method. According to the Sample Size, They Will be Randomly Allocated to the Intervention and Control Groups Using Randomized 4-Block by Table of Random Number.The Sequence of Blocks Will be Placed on a Separate Sheet Inside the Matte Envelope. In the Present Study, We do not Have Blinding.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-01-14, 1398/10/24
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Ethics committee reference number
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IR.ZUMS.REC.1398.436
Health conditions studied
1
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Description of health condition studied
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Pregnancy Nausea and Vomiting
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ICD-10 code
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O21.0
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ICD-10 code description
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Mild hyperemesis gravidarum
Primary outcomes
1
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Description
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Severity of Pregnancy Nausea and Vomiting
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Timepoint
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Before Intervention, Daily up to two Weeks, Immediately After Intervention, and Four Weeks After Intervention
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Method of measurement
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RHODES' Nausea and Vomiting Severity Questionnaire
2
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Description
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Coping With Pregnancy
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Timepoint
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Before Intervention, Immediately After Intervention, and Four Weeks After Intervention
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Method of measurement
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Coping With Pregnancy Questionnaire NuPCI
Secondary outcomes
1
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Description
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Severity of Nausea and Vomiting
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Timepoint
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Before Intervention, The End of The Intervention and 4 Weeks After The Intervention
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Method of measurement
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Reduz Nausea and Vomiting questionnaire
2
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Description
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coping with pregnancy
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Timepoint
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Before Intervention, and 4 weeks after Intervention
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Method of measurement
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Hamilton coping with pregnancy
Intervention groups
1
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Description
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Intervention Group, 6 Sessions Positive Counseling Based on The Protocol of Sligman et al. (2006) will be Received Individually From The 6th Week of Gestation. Each Session will be Done 45 Minutes in Three Times a Week.The Content of The Sessions Includes The Introduction of Three Paths to Happiness (Enjoyment, Commitment, and Meaning in Life) in The Form of a Practice of Forgiveness in Life, a Discussion of Meaning in Life and Its Role in Reducing Negative Emotions, Optimism, Life Satisfaction, Enjoying The Moments and Situations That They Have, Practicing Personal Heritage Skills, Training Subjects to Control Emotions, Acquainting People With Positive Emotions and Its Role in Reducing Pregnancy-related Stressors, Familiarity With One's Abilities and The Role of Support From Other Family Members and Spouse in Adapting to Pregnancy, Reviewing People's Attitudes Towards Commitment and Responsibility in Life and Pregnancy, Practicing The Art of Appreciation in Life, Practicing Thanksgiving in Life, Practicing The Skill of Remembering Three Blessings a Day, Learning to Improve Positive Social Relationships, Constructive Active Response Techniques Will be Discussed.The Control Group Will be Received Only Routine Care, Which Includes Lifestyle Modification to Control Nausea and Vomiting During Pregnancy According to The Protocol of The Ministry of Health,
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Possibility of Dissatisfaction of Participants
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available