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IRCT20221212056786N4 IRCT 2025-06-22 Yazd University of Medical Sciences Comparison of the effectiveness of diazepam and music in managing pain and anxiety during implant surgery Comparison of Diazepam and music premedication effectiveness for management of implant surgery associated pain and anxiety 2025-07-11 anticipated 60 Complete https://irct.ir/trial/84088 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed using the simple random allocation method. First, a random sequence will be generated using PASS 2021 software. The output will be an Excel file containing a sequence of numbers from 1 to 60 and a unique code assigned to each study unit. After generating the random number sequence using the software, the numbers and intervention groups are placed into 60 sealed envelopes. When eligible participants arrive, the envelopes are opened and the individuals are assigned to their respective treatment groups. N/A Implant surgery anxiety; Postoperative pain after implant placement; Immediate implant placement. Intervention 1: Intervention group: One 10 mg Diazepam tablet (Loghman, Tehran, Iran) administered 30 minutes before the start of surgery. Intervention 2: Intervention group: Patients in this group will take one placebo tablet (Ati Pharmed, Karaj, Iran) 30 minutes before surgery and then listen to calming music. The calming music consists of instrumental tracks and is delivered through Sony WH-CH510 headphones (Sony Corporation, Tokyo, Japan). Intervention 3: Control group: Patients will take one placebo tablet (Atipharmed, Karaj, Iran) 30 minutes before surgery. Yes - There is a plan to make this available What will be shared: Yes, there is a plan to share individual participant data (IPD) that have been de-identified, after the completion of the study. The data to be shared will include variables related to the primary outcomes of the study, such as anxiety scores based on the Corah Dental Anxiety Scale and pain scores based on the Visual Analog Scale (VAS). All identifiable information (such as names, national ID numbers, and patient record numbers) will be removed or coded to ensure complete anonymity. The data will be shared exclusively for scientific and research purposes, and only upon formal request by qualified researchers. Access to the data will be granted to applicants with appropriate ethical approvals, and the files will be shared via the corresponding author's email in Excel or SPSS format. When: The data will be made available 6 months after the publication of the study results. To whom: Available to academic researchers or faculty members affiliated with universities. Conditions: The data will be available solely for academic and research purposes, including meta-analyses and systematic reviews, under the condition that the users obtain prior ethical approval and acknowledge the original study. Where to obtain: mohammad arab farashahi sma.farashahi_69@yahoo.com How to obtain: Interested researchers should submit a written request to the corresponding author via email, including a brief description of the research purpose, methodology, and ethical approval. Each request will be reviewed by the study team, and access will be granted upon approval. Comments:
public seyed mohammad arab farashahi
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
Yazd Iran (Islamic Republic of) 8914881167 +98 35 3621 2307 sma.farashahi_69@yahoo.com Yazd University of Medical Sciences scientific seyed mohammad arab farashahi
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
Yazd Iran (Islamic Republic of) 8914881167 035212307 sma.farashahi_69@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age above 18 years Need for tooth extraction between teeth numbers 14 and 24 Immediate implant placement Willingness to participate in the study 18 years no limit Both Alcohol consumption Drug abuse Use of antidepressant medications Use of benzodiazepines Use of muscle relaxants Drug allergies Hearing problems Use of hearing aid Mood disorders Severe anxiety presence of systemic diseases placement of multiple implants receiving pterygoid or zygomatic implants history of previous implant surgeries Treatment - Drugs Other Placebo Intervention group: One 10 mg Diazepam tablet (Loghman, Tehran, Iran) administered 30 minutes before the start of surgery. Intervention group: Patients in this group will take one placebo tablet (Ati Pharmed, Karaj, Iran) 30 minutes before surgery and then listen to calming music. The calming music consists of instrumental tracks and is delivered through Sony WH-CH510 headphones (Sony Corporation, Tokyo, Japan). Control group: Patients will take one placebo tablet (Atipharmed, Karaj, Iran) 30 minutes before surgery. Patients’ anxiety score . Timepoint: At baseline (before surgery) and 30 minutes after the intervention. Method of measurement: Measured using the Corah’s Dental Anxiety Scale (DAS), a validated questionnaire for assessing dental anxiety. Pain intensity. Timepoint: two hours after implant placement. Method of measurement: Measured using the Visual Analog Scale (VAS) for pain. Yazd University of Medical Sciences Approved 2025-01-18 Ethics Committee of Shahid Sadoughi University of Medical Sciences Imam Reza Boulevard, Shahid Sadoughi University of Medical Sciences, School of Dentistry Yazd Yazd Iran (Islamic Republic of)