NCT06670729

Brief Summary

This study compares the psychological effects on patients attend the dental clinic by listening to specific audios

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 30, 2024

Last Update Submit

October 31, 2024

Conditions

Fear AnxietyDiscomfortPsychotherapy Intervention Evaluation

Keywords

Quranfeardiscomfortdentistry

Outcome Measures

Primary Outcomes (2)

  • fear

    fear was assessed using a questionnaire that is based on Dental anxiety scale (DAS) and Modified Dental Anxiety scale (MDAS), statistically significant descending ranks of fear reflects effectiveness of the intervention, when statistical analysis was significant, clinical (practical) effect size was also obtained to determine the clinically effective modality of management

    before, during and immediately after dental session

  • discomfort

    presence or absence of discomfort was assessed using dental anxiety scale and modified dental anxiety scale, descending ranks of fear reflects effectiveness of the intervention

    during and immediately after dental session

Study Arms (2)

Quran listening group

EXPERIMENTAL

participants listen to Quran recitation

Other: Quran listening

silent headphones

OTHER

participant's headphone is silent

Other: silent headphones group

Interventions

Quran listeningOTHER

listening to quran recitation via head phone

Quran listening group
silent headphones groupOTHER

headphones were silent, patient do not listen to any thing

silent headphones

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any patient eligible for dental treatment
  • willing to participate

You may not qualify if:

  • less than 18 years of age,
  • mentally retarded,
  • had hearing impairment or deafness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry

Baghdad, 964, Iraq

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The dentist who provides dental care was blinded to the assignment
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 1, 2024

Study Start

October 26, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 1, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)