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IRCT20241106063622N1 IRCT 2024-11-30 Ahvaz University of Medical Sciences Investigating the Impact of augmented reality glasses on labor pain And Anxiety during the first stage of Labor in primiparous women AR: Augmented reality Investigating the Impact of augmented reality glasses on labor pain And Anxiety during the first stage of Labor in primiparous women 2024-12-21 anticipated 62 Complete https://irct.ir/trial/80071 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be selected based on the inclusion and exclusion criteria and then randomly assigned to intervention and control groups, using a permutation block design. Numbered sealed envelopes will be used for secret allocation. N/A Labor pain and anxiety. Intervention 1: Intervention group: Augmented reality glasses will be used for the intervention group. This device is a smart glasses that connects to a mobile phone or laptop and can create 360-degree and multi-dimensional video. These glasses include sensors such as cameras and lidar that are used to collect environmental information and images. The glasses track the user's location, by placing a digital object on a virtual map, the glasses analyze that object as if it were a real object. And it allows viewing 3D images in the real world. Before starting the study, how to put the glasses on the eyes and how to do the work will be explained to the intervention group. Two different 15-minute videos whose content will include children playing and the mother can interact with them are the content of the sermon. To produce these films, two children playing and performing tricks will be used with the consent of their mothers or through copyright-free films. The first film will be used at 4 to 5 cm dilation and the second film in 7 to 8 cm dilation with augmented reality glasses in a semi-sitting position for 15 minutes. Routine labor care, which includes assessment of vital signs, fetal heart rate, and fetal health assessment, will also be performed in the intervention group. According to the protocol, vaginal examinations will be performed every two hours in the active phase and fetal heart sounds will be measured every half hour. In the second stage of labor, vaginal examinations will be performed every half hour and fetal heart sounds will be measured every 15 minutes. The labor progress of all mothers will be plotted on a partograph form. It should be noted that whenever the mother experiences danger signs that require medical intervention, she will be removed from the program and therefore from the intervention or control group. Intervention 2: Control group: Mothers in the control group will receive routine labor care, including assessment of vital signs, fetal heart rate, and fetal health assessment, similar to mothers in the intervention group. The only difference between the two groups will be that they will not use augmented reality glasses. Vaginal examinations will be performed every two hours during the active phase, and the fetal heart rate will be measured every half hour, according to the protocol. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available.
public Somayeh Makvandi
Ahvaz Jundishapur University., Golestan Highway
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 0000 somayemakvandi@gmail.com Ahvaz University of Medical Sciences scientific Somayeh Makvandi
Ahvaz Jundishapur University., Golestan Highway
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 0000 Somayemakvandi@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iranian primiparous women maternal age between18 to 40 years gestational age 37 to 41 weeks cephalic presentation estimated fetal weight between 2500 and 4000 grams based on sonography presence of three spontaneous contractions in ten minutes three to four centimeters of cervical dilatation normal pelvic examination amniotic sac intact single pregnancy acceptance of augmented reality glasses consent to participate in the study 18 years 40 years Female Presence of any medical and obstetrical diseases and problems Presence of depression according to the Beck questionnaire Vision and hearing problems History of severe headaches and dizziness History of migraines Mother's request for epidural anesthesia Treatment - Devices N/A Intervention group: Augmented reality glasses will be used for the intervention group. This device is a smart glasses that connects to a mobile phone or laptop and can create 360-degree and multi-dimensional video. These glasses include sensors such as cameras and lidar that are used to collect environmental information and images. The glasses track the user's location, by placing a digital object on a virtual map, the glasses analyze that object as if it were a real object. And it allows viewing 3D images in the real world. Before starting the study, how to put the glasses on the eyes and how to do the work will be explained to the intervention group. Two different 15-minute videos whose content will include children playing and the mother can interact with them are the content of the sermon. To produce these films, two children playing and performing tricks will be used with the consent of their mothers or through copyright-free films. The first film will be used at 4 to 5 cm dilation and the second film in 7 to 8 cm dilation with augmented reality glasses in a semi-sitting position for 15 minutes. Routine labor care, which includes assessment of vital signs, fetal heart rate, and fetal health assessment, will also be performed in the intervention group. According to the protocol, vaginal examinations will be performed every two hours in the active phase and fetal heart sounds will be measured every half hour. In the second stage of labor, vaginal examinations will be performed every half hour and fetal heart sounds will be measured every 15 minutes. The labor progress of all mothers will be plotted on a partograph form. It should be noted that whenever the mother experiences danger signs that require medical intervention, she will be removed from the program and therefore from the intervention or control group. Control group: Mothers in the control group will receive routine labor care, including assessment of vital signs, fetal heart rate, and fetal health assessment, similar to mothers in the intervention group. The only difference between the two groups will be that they will not use augmented reality glasses. Vaginal examinations will be performed every two hours during the active phase, and the fetal heart rate will be measured every half hour, according to the protocol. Labor pain score on the Visual analogue Scale pain tool. Timepoint: At the beginning of the study and in cervical dilation of 4 to 5 and 7 to 8 centimeters, immediately before and after the intervention, and at the end of the study in the two intervention and control groups. Method of measurement: To measure pain, a visual analogue scale is used, which is a 100 mm long line with 90 degree angles at each end. Bipolar markers are placed at each end of the line. These end markers cover the full range of possible sensations in the phenomenon being measured. In the present study, the no pain marker will be used at the left end and the worst possible pain marker will be used at the right end. Childbirth anxiety score on the Spielberg questionnaire. Timepoint: At the beginning of the study and in cervical dilation of 4 to 5 and 7 to 8 centimeters, immediately before and after the intervention, and at the end of the study in the two intervention and control groups. Method of measurement: The Spielberg Anxiety Questionnaire will be used to measure the level of anxiety. This test consists of two separate sections, overt and covert anxiety, and in this study, its situational section (overt anxiety), which consists of 20 questions related to fleeting emotional feelings of the subject dependent on specific and fleeting circumstances, will be used. The items of the Spielberg test are assigned a weight between 1 and 4 based on the answers provided. A score of 4 indicates a high level of anxiety, which is how the ten items of the overt anxiety scale are scored. Other items that indicate a lack of anxiety and are given reverse weight when scoring include items: 1-2-5-8-10-11-15-16-19-20. In this test, the anxiety score that can be obtained is between 20 and 80 (39). Scores of 20-30 indicate very mild anxiety, scores of 31-42 indicate mild anxiety, scores of 43-53 indicate moderate anxiety, and scores of 54 and above indicate severe anxiety. Ahvaz University of Medical Sciences Approved 2024-11-02 Ethics Committee of Ahvaz University of Medical Sciences Ahvaz Jundishapur University.,Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)