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IRCT20200130046307N1 IRCT 2020-02-08 Mashhad University of Medical Sciences The effect of intervention based on health belief model on parent's anxiety, follow up examinations and velocity of retinal vascularization in retinopathy of prematurity ندارد The effect of intervention based on health belief model on parent's anxiety, follow up examinations and velocity of retinal vascularization in retinopathy of prematurity 2020-02-09 anticipated 60 Complete https://irct.ir/trial/45577 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Balanced Block Randomization, Blinding description: In terms of sampling method, infants will be included in the study in a non-random way. Randomization will be the Balanced Block Randomization method. N/A Condition 1: retinopathy of prematurity. Condition 2: health belief model. Condition 3: Situational anxiety. Intervention group: This randomized controlled clinical trial will be performed on at least 60 infants with premature retinopathy and their parents referring to ROP Clinic of Khatam Al Anbia Eye Hospital in Mashhad, Iran, in 1389-99. Was. In terms of sampling method, infants will be admitted to the study in a non-random way. The sampling process will take approximately 2 months and the sample will be sampled 10% more than the specified number.The randomization method will be a balanced rendering block.After completing the selection form of research units and consenting to participate in the study, researcher-made questionnaires of Health Belief and Anxiety will be completed by intervention and control group and then it will be examined which parents have more problems in model model and structures. To emphasize that part at the planning stage. The intervention program will be implemented in 6 sessions of 45-60 minutes in the form of lecture, group discussion, question and answer and film and slide show. At the end of each session, the materials will be provided as educational pamphlets.The sessions will be held at the ROP Unit of Khatam Al Anbia Eye Hospital in Mashhad. The content of the training will include empowering parents to abide by treatment, timely follow-up examinations, care needs of the premature infant, control of the baby's pain at the time of eye examination, sleep patterns and nutrition of the infant, and parent stress management and anxiety. The intervention will be based on the constructs of the Health Belief Model as follows: In accordance with the Health Belief Model, the first step will be to create perceived sensitivity through speech, group discussion, poster and slide show, parents with retinopathy problems and problems Familiar with and highlighting the complications and risks of diseases of this period, relative to leprosy Periodic examinations and screenings will be sensitive.By constructing concrete examples and displaying photographs of infants who have been blinded by weakness and failure to care, the perceived structure will be highlighted. An instructional pamphlet and telephone reminder as well as the role of spouses (in building positive beliefs on the opposite side) will be used to build the practice guide. To create perceived benefits, parents will try to believe that they are capable of taking care of the premature baby themselves. Secondly, these cares are not difficult and will not cost them a lot (Structures perceived barriers). In order to construct self-efficacy, caring behaviors are divided into smaller components, practically demonstrated through parenting, and they will be encouraged to do so. Research units will be encouraged to discuss the obstacles and problems encountered in the group or to use the researcher's telephone guidance if necessary. The control group will receive routine ROP training. Research units will be given the opportunity to repeat and practice the training for one month and may need help and advice if needed during this period or by phone call to the researcher if necessary. To receive.During this one month, health messages will be sent to research units twice a week (re-highlighting the practice guideline). The Health Belief and Anxiety Questionnaires will be provided to the experimental and control groups immediately and one month after the intervention. Again, the questionnaires will be evaluated and compared with before the intervention. Also, compliance of the intervention and control groups with timely referral to the neonate will be assessed based on the State Regulatory Board of Retinopathy in the preterm infants. The first examination will be diagnosed by the retina stage and disease area specialist in the infant and will be followed by a follow-up examination in accordance with the National Regulatory Board for Retinopathy Care Schedule.Subsequent examinations will be performed until the neonatal retinal vascularization is completed. Considering that adherence to follow-up visits is one of the key elements in the treatment process, parental follow-up and follow-up are The intervention and control groups will be evaluated. How to follow-up examinations include, exactly on the day of examination, 1 to 2 days delayed phone recall, 3 weeks delayed phone recall, more than one week delayed recall, non-attendance despite phone reminders.It should be noted, in view of the importance of follow-up examinations if the intervention and control groups were delayed for more than one week despite telephone reminders, in accordance with the procedure in the premature neonatal clinic of Khatam Al Anbia Specialty Hospital Telephone reminders will continue for all clients, if no referral is made, correspondence with comprehensive health centers and if necessary visit the patient's home through comprehensive health centers to justify parents and ensure referral to the baby to continue the process. Treatment and examinations will be performed.Neonatal retinal vascularization in the intervention and control groups will be initially evaluated by an ophthalmologist. This evaluation will continue until the neonatal retinal vascularization is completed in both the intervention and control groups. In this study, premature neonates who are in stage 2 and area 2 will be enrolled in the study. Vascularization rates will be compared to neonatal arrival time to Posterior 2, Posterior 2, Anterior 2, Posterior 3, and Vascularization, respectively.The control group will receive all routine services and training of the premature neonatal clinic at Khatam Al Anbia Specialist Hospital, which will be provided to all clients. At the premature neonatal clinic, after obtaining the consent of the patient, screening examinations will be performed by the retina specialist. Subsequent examinations will be scheduled until the end of vascularization according to the stage and area of ​​the eye involvement. Training provided to parents of premature infants will be performed by a skilled Nursing Expert with experience in the ROP unit who will answer parental questions and provide educational pamphlets.. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared after unidentifiable people When: Start of access period 6 months after printing results To whom: researchers Conditions: For academic studies, Information about the main outcome can be shared after unidentifiable people Where to obtain: salehnezhada2@mums.ac.ir _ Azam Salehnezhad How to obtain: send mail Comments: -
public Azam Salehnezhad
Gas-Fourteen-Gas Street-Habib Ibn Mazaher Six-Plate 564
Mashhad Iran (Islamic Republic of) 091487774158 +98 51 3270 4195 salehnezhada2@mums.ac.ir Mashhad University of Medical Sciences scientific Zahra Emami moghadam
School of Nursing and Midwifery, University of Medical Sciences, Mashhad, Khorasan Razavi, Mashhad
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 EmamiZ@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Parent Criteria for Inclusion: Having written consent to participate in the study, having read and write literacy. Test scores above 30 in the Spiel Berger Situational Anxiety Questionnaire. Inclusion criteria for neonates: Research unit infants with gestational age of 34 weeks (33 weeks and 6 days or less), infants weighing 2000 g or less, neonates with zone 2 and stage 2 retina screening examination. no limit no limit Both Exclusion criteria for parents: unwillingness of the research unit to continue cooperating, having depression or anxiety disorder confirmed by a specialist physician during the study, participating in a similar training program during the study, more than one absenteeism session, history of maintenance An infant with retinopathy of prematurity, severe stressful events such as the death of first-degree relatives, divorces, or severe family disputes during the study. Exclusion criteria for neonates: neonatal death, clinical instability, and outpatient referral, such as hospitalization in the ICU, incidence of respiratory distress syndrome and need for mechanical ventilation during the study, severe asphyxia, and congenital major malformations retinopath health bel Situationa retinopathy of prematurity health belief model Situational anxiety Other Intervention group: This randomized controlled clinical trial will be performed on at least 60 infants with premature retinopathy and their parents referring to ROP Clinic of Khatam Al Anbia Eye Hospital in Mashhad, Iran, in 1389-99. Was. In terms of sampling method, infants will be admitted to the study in a non-random way. The sampling process will take approximately 2 months and the sample will be sampled 10% more than the specified number.The randomization method will be a balanced rendering block.After completing the selection form of research units and consenting to participate in the study, researcher-made questionnaires of Health Belief and Anxiety will be completed by intervention and control group and then it will be examined which parents have more problems in model model and structures. To emphasize that part at the planning stage. The intervention program will be implemented in 6 sessions of 45-60 minutes in the form of lecture, group discussion, question and answer and film and slide show. At the end of each session, the materials will be provided as educational pamphlets.The sessions will be held at the ROP Unit of Khatam Al Anbia Eye Hospital in Mashhad. The content of the training will include empowering parents to abide by treatment, timely follow-up examinations, care needs of the premature infant, control of the baby's pain at the time of eye examination, sleep patterns and nutrition of the infant, and parent stress management and anxiety. The intervention will be based on the constructs of the Health Belief Model as follows: In accordance with the Health Belief Model, the first step will be to create perceived sensitivity through speech, group discussion, poster and slide show, parents with retinopathy problems and problems Familiar with and highlighting the complications and risks of diseases of this period, relative to leprosy Periodic examinations and screenings will be sensitive.By constructing concrete examples and displaying photographs of infants who have been blinded by weakness and failure to care, the perceived structure will be highlighted. An instructional pamphlet and telephone reminder as well as the role of spouses (in building positive beliefs on the opposite side) will be used to build the practice guide. To create perceived benefits, parents will try to believe that they are capable of taking care of the premature baby themselves. Secondly, these cares are not difficult and will not cost them a lot (Structures perceived barriers). In order to construct self-efficacy, caring behaviors are divided into smaller components, practically demonstrated through parenting, and they will be encouraged to do so. Research units will be encouraged to discuss the obstacles and problems encountered in the group or to use the researcher's telephone guidance if necessary. The control group will receive routine ROP training. Research units will be given the opportunity to repeat and practice the training for one month and may need help and advice if needed during this period or by phone call to the researcher if necessary. To receive.During this one month, health messages will be sent to research units twice a week (re-highlighting the practice guideline). The Health Belief and Anxiety Questionnaires will be provided to the experimental and control groups immediately and one month after the intervention. Again, the questionnaires will be evaluated and compared with before the intervention. Also, compliance of the intervention and control groups with timely referral to the neonate will be assessed based on the State Regulatory Board of Retinopathy in the preterm infants. The first examination will be diagnosed by the retina stage and disease area specialist in the infant and will be followed by a follow-up examination in accordance with the National Regulatory Board for Retinopathy Care Schedule.Subsequent examinations will be performed until the neonatal retinal vascularization is completed. Considering that adherence to follow-up visits is one of the key elements in the treatment process, parental follow-up and follow-up are The intervention and control groups will be evaluated. How to follow-up examinations include, exactly on the day of examination, 1 to 2 days delayed phone recall, 3 weeks delayed phone recall, more than one week delayed recall, non-attendance despite phone reminders.It should be noted, in view of the importance of follow-up examinations if the intervention and control groups were delayed for more than one week despite telephone reminders, in accordance with the procedure in the premature neonatal clinic of Khatam Al Anbia Specialty Hospital Telephone reminders will continue for all clients, if no referral is made, correspondence with comprehensive health centers and if necessary visit the patient's home through comprehensive health centers to justify parents and ensure referral to the baby to continue the process. Treatment and examinations will be performed.Neonatal retinal vascularization in the intervention and control groups will be initially evaluated by an ophthalmologist. This evaluation will continue until the neonatal retinal vascularization is completed in both the intervention and control groups. In this study, premature neonates who are in stage 2 and area 2 will be enrolled in the study. Vascularization rates will be compared to neonatal arrival time to Posterior 2, Posterior 2, Anterior 2, Posterior 3, and Vascularization, respectively.The control group will receive all routine services and training of the premature neonatal clinic at Khatam Al Anbia Specialist Hospital, which will be provided to all clients. At the premature neonatal clinic, after obtaining the consent of the patient, screening examinations will be performed by the retina specialist. Subsequent examinations will be scheduled until the end of vascularization according to the stage and area of ​​the eye involvement. Training provided to parents of premature infants will be performed by a skilled Nursing Expert with experience in the ROP unit who will answer parental questions and provide educational pamphlets. Parental Anxiety of Neonates with Retinopathy. Timepoint: Parental anxiety of neonates with retinopathy of prematurity, at baseline (before intervention), immediately after intervention. Method of measurement: Standard Spellberger questionnaire. Parental adherence to the follow-up screening program for infants with retinopathy of prematurity. Timepoint: According to the schedule prescribed by the treating physician. Method of measurement: Form made by the researcher. Velocity of retinal vascularization in retinopathy of prematurity. Timepoint: In accordance with Schedule of follow-up examinations in Retinopathy Executive Regulations. Method of measurement: Comparison of neonatal admission time to Posterior 2, Posterior 2, Anterior 2, Posterior 3 and Vascularization, respectively. Mashhad University of Medical Sciences Approved 2019-11-12 Ethics Committee of School of Nursing and Midwifery- Mashhad University of Medical Sciences School of Nursing and Midwifery, University of Medical Sciences, Mashhad, Khorasan Razavi, Mashhad mashhad Razavi Khorasan Iran (Islamic Republic of)