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IRCT20190129042544N1 IRCT 2023-06-26 Ahvaz University of Medical Sciences The impact of psycho-social support interventions on pregnancy outcomes. Investigating the effectiveness of an intervention based on psychosocial support compared to standard care on pregnancy outcomes in adolescent pregnancy. 2023-06-20 anticipated 84 Complete https://irct.ir/trial/70365 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This research is a multi-method mixed study, that is, the data have been collected, analyzed and integrated with each other with qualitative and quantitative approaches during several stages. In the first stage, the psychosocial support needs of pregnant teenagers are explained with the qualitative approach of guided content analysis. In the second stage, formulation of the intervention based on the solutions extracted from the qualitative stage and a review of the texts, prioritization and consensus on the selection of the intervention to promote psychosocial support provided based on the views of the experts using the nominal group method. And after analyzing the quantitative data and qualitatively, their results will be compared and combined, Randomization description: "Due to the limited number of teenage pregnant mothers and the nature of the clinical trial, the researcher will refer to health centers in the east and west of Ahvaz to determine eligible and willing mothers to participate in the study. If the desired sample volume is not provided, the researcher will continue to other centers until reaching the desired sample volume. The samples will then be divided into two groups, an intervention group, and a control group, using the random block method. All possible modes of placement of letters A (intervention) and B (control) will be considered in blocks of 6 with an allocation ratio of 1:1. The number of required blocks will be determined based on the number of studied samples. Then, based on the table of random numbers and the number of required blocks, the blocks corresponding to each table number will be listed in order. When the samples enter the study, each person will be assigned a certain letter according to the obtained order. For example, according to the order (AAABBB/ABABAB), the seventh person will be placed in the intervention group (A). To hide the allocation, sequentially numbered sealed envelopes will be used, with the type of intervention written inside. To hide the random allocation, the method of non-transparent sealed envelopes with random sequences will be used. First, a random sequence will be created by a person who is unaware of the goals and subject of the study. Based on the sample size of the research (84 people), 84 opaque envelopes will be prepared. Each of the random sequences created by the person will be recorded on a card, and the cards will be placed in the envelopes in order. Finally, the envelopes will be sealed and placed in a box, which will be kept by the midwife of the center. When the researcher starts sampling, one of the envelopes will be opened based on the order in which the eligible participants entered the study, and the specialized group of that participant will be revealed. Due to the nature of this study, it will not be possible to blind the researcher and the participant. However, the results of the questionnaires will be collected by another person who is not aware of the study's objectives.", Blinding description: Due to the nature of this study, it will not be possible to blind the researcher and the participant, but the results of the questionnaires will be collected by another person who is not aware of the objectives of the study. N/A Condition 1: Social support. Condition 2: Perceived Stress. Condition 3: Depression. Condition 4: anger expression. Intervention 1: Intervention group: In the intervention group, participants will receive 4-6 training sessions based on psychosocial support. Depending on the content, the number of sessions may vary. Group sessions of 4 to 10 people will be offered during pregnancy. Intervention 2: Control group: In the control group, only routine supportive care will be provided by the researcher. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: starting 9 months after publication To whom: people working in academic institutions Conditions: with previous agreement with the corresponding author Where to obtain: email address:yousefi.setareh@gmail.com How to obtain: email address: yousefi.setareh@gmail.com Comments:
public Simin Montazeri
Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran
Ahvaz Iran (Islamic Republic of) 15794 61357 +98 61 3311 0000 mrssiminmontazeri@yahoo.com Ahvaz University of Medical Sciences scientific Simin Montazeri
Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran.
Ahvaz Iran (Islamic Republic of) 15794 61357 0098 61 3373858 mrssiminmontazeri@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Ability to understand and speak Persian Low-risk singleton pregnancy Gestational age 12-28 weeks Being literate in reading and writing Being at the age of 13-19 years old 13 years 19 years Female Discovering abnormalities in the fetus Having a known physical or mental illness Consumption of alcohol and tobacco by the mother Z73.3 F53.1 R45.4 Stress, not elsewhere classified Severe mental and behavioural disorders associated with the puerperium, not elsewhere classified Irritability and anger Behavior Lifestyle Intervention group: In the intervention group, participants will receive 4-6 training sessions based on psychosocial support. Depending on the content, the number of sessions may vary. Group sessions of 4 to 10 people will be offered during pregnancy. Control group: In the control group, only routine supportive care will be provided by the researcher. Social support. Timepoint: Before intervention and after the sessions are completed and one month after the intervention. Method of measurement: Vaux social support. Spielberger anger expression scale score. Timepoint: Before intervention and after the sessions are completed and one month after the intervention. Method of measurement: Spielberger anger expression scale. Depression. Timepoint: Before intervention and after the sessions are completed and one month after the intervention. Method of measurement: Depression Edinburgh EDS. Perceived Stress. Timepoint: Before intervention and after the sessions are completed and one month after the intervention. Method of measurement: Perceived Stress Scale. Pregnancy outcome in mental health. Timepoint: Before intervention and after the sessions are completed and one month after the intervention. Method of measurement: Perceived Stress Scale-Depression Edinburgh EDS-Spielberger anger expression scale score. Ahvaz University of Medical Sciences Approved 2023-06-03 Research Ethics Committees of Ahvaz Jondishapur University of Medical Sciences Ahvaz Jondishapur University of Medical Sciences; Golestan street Ahvaz Khouzestan Iran (Islamic Republic of)