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Active Not Recruiting NCT07936305

Virtual Reality Headset Intervention on Pain, Anxiety, and Vital Signs in Pregnant Women Following Vaccination

Conditions: Pregnancy Related, Pain, Anxiety, Vital Signs

Sex: All
Ages: 19 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 200
Sponsor: Serpil Uyar

Location: Afyonkarahisar Family Health Centre No. 6 Afyonkarahisar

Summary

Our study aims to investigate the impact of virtual reality headset use on pain, anxiety, and vital signs in pregnant women after they receive a vaccine. Pain and anxiety will be assessed using relevant scales, while vital signs-specifically blood pressure, pulse, and oxygen saturation-will be measured using a blood pressure monitor and a pulse oximeter. The study is conducted at the Afyonkarahisar Family Health Centre No. 6-the facility where the researcher is employed-between December 1, 2025, and December 1, 2026. This location was selected to facilitate access to the target group, ensure an efficient and reliable data collection process, and enhance the overall feasibility of the research. The study population will consist of pregnant women who visit the Family Health Centre for pregnancy follow-ups or vaccinations during the specified study period. The research will involve two groups: one control group (Group 1) and one intervention group (Group 2). Given the interventional nature of this study-and noting that no existing literature could be found examining the effects of virtual reality (VR) headsets on anxiety, pain, or vital signs in pregnant women undergoing vaccination-a pilot study involving at least 30 participants will be conducted first. Subsequently, a power analysis will be performed using the G\*Power 3.1 software to determine the final sample size. The projected sample size is 100 participants for Group 1 and 100 for Group 2, totalling 200 participants. Assignment to the intervention and control groups will take place when pregnant women who meet the inclusion criteria arrive at Family Health Centre No. 06. A sealed-envelope method will be used to ensure randomisation when allocating the pregnant women into the intervention and control groups. Envelopes will contain slips of paper marked with either an odd or an even number. Those who select an odd number will be assigned to the control group (Group 1), while those who select an even number will be assigned to the intervention group (Group 2). A single-blind approach will be employed, in which the individuals responsible for entering data into the SPSS software and those conducting the statistical analyses will be blinded. Data entry will be performed by individuals who have no knowledge of the study groups, and statistical analyses will be conducted by a statistician who is also unaware of the study groups. Data for the study will be collected using a sociodemographic characteristics form, a pre-vaccination pregnancy monitoring form, and a post-vaccination pregnancy monitoring form. All pregnant women arriving for vaccination who meet the inclusion criteria will be provided with information about the study, after which they will complete a sociodemographic characteristics form. Subsequently, participants will be randomised into groups using an envelope method. Group 1 (Control Group) will not watch a pre-vaccination video via virtual reality (VR) headsets; however, data will be collected using a pre-vaccination monitoring form (before the vaccination) and a post-vaccination monitoring form (after the vaccination). Group 2 (Experimental Group) will first complete the pre-vaccination monitoring form, followed by a 5-minute video session using VR headsets. The vaccination will be administered after the video, and data will be collected 5 minutes post-vaccination using the post-vaccination monitoring form. Since the virtual reality intervention in our study is specific to the pre-vaccination period, applying it to the control group at a later stage would not be methodologically appropriate. In this study, the administration of the virtual reality intervention, the recording of vital signs, and the completion of the forms will be carried out by the researcher.

Eligibility Criteria

Inclusion Criteria: * Voluntary participation * Aged between 19 and 45 * Being Pregnant * Without any hearing, vision, speech, or understanding issues. Exclusion Criteria: * With a diagnosed psychiatric disorder * With an intellectual disability or communication difficulties * With vision or hearing issues * With vertigo

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07936305). StuddyBuddy aggregates publicly available trial information.