]>
IRCT20240123060774N1 IRCT 2024-03-02 Yazd University of Medical Sciences Couple CARE program and flourishing model PERMA on the quality of the relationship, the relationship of the couple in the disease, and the desire to have children again in high-risk pregnancy Effectiveness comparison of the Couple CARE (Couple Commitment and Relationship Enhancement) program versus flourishing model PERMA (Positive Emotion, Engagement, Relationships, Meaning, and Accomplishments) in an online method on the quality of the relationship, the relationship of the couple in the disease and the desire to have children again in high-risk pregnancy 2024-04-24 anticipated 72 Complete https://irct.ir/trial/75197 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible couples, referring to Shahid Sadouqi Hospital and Shohada Kargar Hospital in Yazd city, are sampled based on the criteria of participating in the study using the available method. The permutation block method obtains the randomization sequence, considering blocks of size 4, using the site www.random.org/sequences. Couples are allocated to two intervention groups the Care Program for Couples (CARE) or the PERMA model (PERMA). They are randomly selected (each group has 36 participants). Concealment is done in random allocation so that neither the researcher nor the women nor their spouses know which of the two groups they will be allocated to. N/A High-risk pregnancy. Intervention 1: Intervention group: The intervention is carried out by a senior counseling student in midwifery who has the certificate and skill to perform the intervention under the supervision of the supervisor (reproductive health specialist and clinical psychologist) and the consultant professor (doctorate in nursing). The intervention for the couple is done online in the space of one of the Iranian messengers as a group in 6 sessions of 90 minutes, once a week. The intervention in the first group (PERMA model) includes an introduction of PERMA elements, the first element of PERMA is positive emotions and their role in life, the second element of PERMA is fascination and methods of increasing immersion, the third element of PERMA is meaning and connection with well-being, the fourth element of PERMA is positive relationships and evaluation of the quality of communication, the fifth element of PERMA is achievement/success and its importance in life. Then, the conclusion includes the summation and post-test implementation. For this group, before the start of the intervention, the link to the online counseling sessions in Skyroom will be sent along with the training video on how to use Skyroom and how to complete the questionnaires in the Iranian messenger group. Also, on the day of the meetings, they will be reminded again by sending an SMS about the start of the meetings along with the link related to the meetings. At the beginning of each meeting, a summary of the materials related to the previous meetings will be reviewed and the assigned tasks related to the previous meeting will be reviewed by the consultant to measure the improvement of the relationship in each meeting. Couples are asked to participate in online counseling discussions and ask questions. The consultant will also ask questions about the topics of the meeting for the participation of more people. Women are asked to share what they learned in the sessions with their husbands and do the exercises with their participation. In case of absence from the video counseling session, the counseling session will be available to the absent person offline. In case of internet interruption or problems in the online holding system, counseling sessions will be held on another day with the coordination of group members. At the end of each session, a summary of the important topics discussed is presented people's questions are answered, and women are asked to do home exercises until the next session. Intervention 2: Control group: The intervention is carried out by a senior counseling student in midwifery who has the certificate and skill to perform the intervention under the supervision of the supervisor (reproductive health specialist and clinical psychologist) and the consultant professor (doctorate in nursing). The intervention for the couple is done online in the space of an Iranian messenger as a group in 6 sessions of 90 minutes, once a week. Intervention in the Couple CARE group (Couple Commitment and Relationship Enhancement) includes an introduction, initiation of self-change, interaction, intimacy, and care, meaning of differences, sexual relations, looking to the future in communication, and evaluating and monitoring the process of changes in the couple relationship. For this group, before the start of the intervention, the link to the online counseling sessions in Skyroom will be sent along with the training video on how to use Skyroom and how to complete the questionnaires in the Iranian messenger group. Also, on the day of the meetings, they will be reminded again by sending an SMS about the start of the meetings along with the link related to the meetings. At the beginning of each meeting, a summary of the materials related to the previous meetings will be reviewed and the assigned tasks related to the previous meeting will be reviewed by the consultant to measure the improvement of the relationship in each meeting. Couples are asked to participate in online counseling discussions and ask questions. The consultant will also ask questions about the topics of the meeting for more participation and involvement of samples in the meeting. Women are asked to share what they learned in the sessions with their husbands and do the exercises with their participation. In case of absence from the video counseling session, the counseling session will be available to the absent person offline. In case of internet interruption or problems in the online holding system, counseling sessions will be held on another day with the coordination of group members. At the end of each session, a summary of the important topics discussed is presented people's questions are answered, and women are asked to do home exercises until the next session. Yes - There is a plan to make this available What will be shared: All individual data of the study participants can be shared after de-identification. When: After publishing the results To whom: The data will be available to researchers working in academic and scientific institutions, and people in the industry can also apply to receive them. Conditions: Scientific Application Where to obtain: farajkhoda_t@yahoo.com How to obtain: One week after receiving the applicant's email Comments:
public Tahmine Faraj Khoda
Bu Ali St, Yazd
Yazd Iran (Islamic Republic of) 8916877443 +98 35 1751 3824 farajkhoda_t@yahoo.com Yazd University of Medical Sciences scientific Tahmineh Farajkhoda
Bouali ave
Yazd Iran (Islamic Republic of) 8916877443 +98 35 3824 1754 farajkhoda_t@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Married pregnant women with a live fetus from the beginning of pregnancy to 28 weeks with a high-risk pregnancy diagnosis by a doctor and having a high-risk pregnancy record Ability to participate in online counseling sessions for couples Having an Android or iOS smart phone Persian dialect Consent to participate in research Undesirable score of couple relationship in disease Having a marital relationship no limit no limit Both Self-declaration of the couple or for women, inclusion in the women's medical record of suffering from neuropsychiatric disorders Treated with psychiatric drugs Drug and alcohol addiction Speech/hearing problems Simultaneous participation in other similar studies O09 Supervision of high risk pregnancy Behavior Behavior Intervention group: The intervention is carried out by a senior counseling student in midwifery who has the certificate and skill to perform the intervention under the supervision of the supervisor (reproductive health specialist and clinical psychologist) and the consultant professor (doctorate in nursing). The intervention for the couple is done online in the space of one of the Iranian messengers as a group in 6 sessions of 90 minutes, once a week. The intervention in the first group (PERMA model) includes an introduction of PERMA elements, the first element of PERMA is positive emotions and their role in life, the second element of PERMA is fascination and methods of increasing immersion, the third element of PERMA is meaning and connection with well-being, the fourth element of PERMA is positive relationships and evaluation of the quality of communication, the fifth element of PERMA is achievement/success and its importance in life. Then, the conclusion includes the summation and post-test implementation. For this group, before the start of the intervention, the link to the online counseling sessions in Skyroom will be sent along with the training video on how to use Skyroom and how to complete the questionnaires in the Iranian messenger group. Also, on the day of the meetings, they will be reminded again by sending an SMS about the start of the meetings along with the link related to the meetings. At the beginning of each meeting, a summary of the materials related to the previous meetings will be reviewed and the assigned tasks related to the previous meeting will be reviewed by the consultant to measure the improvement of the relationship in each meeting. Couples are asked to participate in online counseling discussions and ask questions. The consultant will also ask questions about the topics of the meeting for the participation of more people. Women are asked to share what they learned in the sessions with their husbands and do the exercises with their participation. In case of absence from the video counseling session, the counseling session will be available to the absent person offline. In case of internet interruption or problems in the online holding system, counseling sessions will be held on another day with the coordination of group members. At the end of each session, a summary of the important topics discussed is presented people's questions are answered, and women are asked to do home exercises until the next session. Control group: The intervention is carried out by a senior counseling student in midwifery who has the certificate and skill to perform the intervention under the supervision of the supervisor (reproductive health specialist and clinical psychologist) and the consultant professor (doctorate in nursing). The intervention for the couple is done online in the space of an Iranian messenger as a group in 6 sessions of 90 minutes, once a week. Intervention in the Couple CARE group (Couple Commitment and Relationship Enhancement) includes an introduction, initiation of self-change, interaction, intimacy, and care, meaning of differences, sexual relations, looking to the future in communication, and evaluating and monitoring the process of changes in the couple relationship. For this group, before the start of the intervention, the link to the online counseling sessions in Skyroom will be sent along with the training video on how to use Skyroom and how to complete the questionnaires in the Iranian messenger group. Also, on the day of the meetings, they will be reminded again by sending an SMS about the start of the meetings along with the link related to the meetings. At the beginning of each meeting, a summary of the materials related to the previous meetings will be reviewed and the assigned tasks related to the previous meeting will be reviewed by the consultant to measure the improvement of the relationship in each meeting. Couples are asked to participate in online counseling discussions and ask questions. The consultant will also ask questions about the topics of the meeting for more participation and involvement of samples in the meeting. Women are asked to share what they learned in the sessions with their husbands and do the exercises with their participation. In case of absence from the video counseling session, the counseling session will be available to the absent person offline. In case of internet interruption or problems in the online holding system, counseling sessions will be held on another day with the coordination of group members. At the end of each session, a summary of the important topics discussed is presented people's questions are answered, and women are asked to do home exercises until the next session. The quality of the couple's relationship. Timepoint: Baseline, completion of the intervention in week 6 and completion of the study in week 10. Method of measurement: Questionnaire of the quality of couple relations by Kennedy et al. (2016). Couple relationship in illness. Timepoint: Baseline, completion of the intervention in week 6 and completion of the study in week 10. Method of measurement: Couple Relationship Scale Questionnaire in Illness. The desire to have children again. Timepoint: Baseline, completion of the intervention in week 6 and completion of the study in week 10. Method of measurement: With a question on a visual scale between 1-10, "How willing are you to have children again?". Yazd University of Medical Sciences Approved 2024-02-03 Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Research and Technology Vice-Chancellor, Imam Reza (AS) Complex, Imam Hossein Square, Yazd Yazd Yazd Iran (Islamic Republic of)