Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:32 AM
Study NCT ID:
NCT07458451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nature Sounds During Dental Filling on Anxiety in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State Anxiety Score (State-Trait Anxiety Inventory - STAI)', 'timeFrame': 'Before the dental filling procedure and immediately after the procedure (approximately 15-30 minutes)', 'description': 'Change in state anxiety levels measured using the State-Trait Anxiety Inventory (State Anxiety subscale) before and after the dental filling procedure.'}], 'secondaryOutcomes': [{'measure': 'Fear Level (Visual Analog Scale)', 'timeFrame': 'Before the dental filling procedure and immediately after the procedure', 'description': 'Fear intensity measured using a 0-10 Visual Analog Scale (VAS), where higher scores indicate greater fear related to the dental procedure.'}, {'measure': 'Patient Satisfaction (Visual Analog Scale)', 'timeFrame': 'Immediately after the dental filling procedure', 'description': 'Patient satisfaction with the dental filling procedure measured using a 0-10 Visual Analog Scale (VAS), where higher scores indicate greater satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nature Sounds', 'Dental Anxiety', 'Dental Filling', 'Older Adults', 'White Noise', 'Patient Satisfaction', 'Randomized Controlled Trial'], 'conditions': ['Dental Anxiety']}, 'descriptionModule': {'briefSummary': 'Dental anxiety is common among older adults and may lead to delayed or avoided dental treatment, which can negatively affect oral health. Non-pharmacological approaches such as auditory interventions have been suggested as simple methods to reduce anxiety during dental procedures.\n\nThe aim of this randomized controlled study is to evaluate the effect of listening to nature sounds during dental filling procedures on anxiety, fear, and patient satisfaction in older adults. The study will be conducted at Artvin Oral and Dental Health Center with individuals aged 65 years and older who require dental filling treatment.\n\nParticipants will be randomly assigned to one of three groups: a nature sound group, a white noise (placebo) group, and a control group. Individuals in the nature sound group will listen to recorded natural sounds, including ocean waves, bird songs, and light rain, through wireless headphones for 15 minutes during the dental filling procedure. Participants in the placebo group will listen to white noise for the same duration, while the control group will receive routine dental treatment without any auditory intervention.\n\nAnxiety, fear, and patient satisfaction will be measured before and after the dental procedure using standardized assessment tools, including the State-Trait Anxiety Inventory and visual analog scales. The results of this study may provide evidence on whether natural sound exposure can be an effective, simple, and non-invasive method to reduce anxiety and improve patient comfort during dental procedures in older adults.', 'detailedDescription': 'Dental anxiety is a common problem among older adults and may lead to avoidance or delay of necessary dental treatment. High levels of dental anxiety are associated with poorer oral health outcomes, reduced treatment compliance, and decreased patient satisfaction. Dental procedures such as dental filling treatments may increase fear and anxiety due to perceived pain, noise from dental equipment, and loss of control during the procedure. Therefore, developing simple and non-pharmacological strategies to reduce anxiety during dental treatment is important for improving patient comfort and treatment outcomes.\n\nNatural environmental sounds have been shown to have relaxing and stress-reducing effects in various healthcare settings. Exposure to sounds such as ocean waves, bird songs, and rainfall has been associated with reduced stress, improved mood, and enhanced recovery in patients undergoing medical procedures. However, there is limited evidence regarding the effects of natural sounds on anxiety and fear during dental procedures, particularly among older adults.\n\nThis study aims to evaluate the effect of listening to nature sounds during dental filling procedures on anxiety, fear, and patient satisfaction in older adults. The study will be designed as a randomized, placebo-controlled experimental trial conducted at the Artvin Oral and Dental Health Center. Individuals aged 65 years and older who require dental filling treatment and meet the inclusion criteria will be invited to participate in the study. After providing informed consent, participants will be randomly assigned to one of three groups: a nature sound intervention group, a white noise placebo group, or a control group.\n\nParticipants in the intervention group will listen to recorded nature sounds, including ocean waves, bird songs, and light rain, through wireless headphones for 15 minutes during the dental filling procedure. Participants in the placebo group will listen to white noise through headphones for the same duration, while participants in the control group will receive routine dental treatment without any auditory intervention.\n\nData will be collected before and after the dental procedure. Participants will complete a patient information form and standardized assessment tools. Anxiety will be assessed using the State-Trait Anxiety Inventory (state anxiety section), while fear and patient satisfaction will be evaluated using Visual Analog Scales (VAS). Cognitive status will be screened using the Mini-Mental State Examination to ensure participant eligibility.\n\nThe collected data will be analyzed using statistical software. Descriptive statistics will be calculated for demographic and clinical variables. Differences between groups and time points will be evaluated using appropriate statistical tests, including repeated measures analyses. The results of this study may provide evidence regarding the effectiveness of natural sound interventions as a simple and non-invasive approach to reduce anxiety and improve patient experience during dental procedures in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years or older\n* Patients scheduled to undergo dental filling treatment\n* Mini-Mental State Examination (MMSE) score ≥ 24\n* Ability to communicate and understand study procedures\n* No hearing impairment that would prevent listening to audio through headphones\n* Willingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* Use of antidepressant medications\n* Presence of severe cognitive impairment (MMSE \\< 24)\n* Hearing impairment preventing participation in the auditory intervention\n* Communication problems that may interfere with questionnaire completion\n* Refusal or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07458451', 'briefTitle': 'Effect of Nature Sounds During Dental Filling on Anxiety in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Artvin Coruh University'}, 'officialTitle': 'The Effect of Listening to Nature Sounds During Dental Filling Procedures on Anxiety, Fear, and Patient Satisfaction in Older Adults', 'orgStudyIdInfo': {'id': 'ACU-NS-2026-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nature Sounds Group', 'description': 'Participants will listen to recorded natural sounds including ocean waves, bird songs, and light rain through wireless headphones for 15 minutes during the dental filling procedure.', 'interventionNames': ['Behavioral: Nature Sounds']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'White Noise Group', 'description': 'Participants will listen to white noise through headphones for 15 minutes during the dental filling procedure.', 'interventionNames': ['Other: White Noise']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will receive routine dental filling treatment without any auditory intervention.'}], 'interventions': [{'name': 'Nature Sounds', 'type': 'BEHAVIORAL', 'description': 'Participants will listen to recorded natural sounds including ocean waves, bird songs, and light rain through wireless headphones for 15 minutes during the dental filling procedure.', 'armGroupLabels': ['Nature Sounds Group']}, {'name': 'White Noise', 'type': 'OTHER', 'description': 'Participants will listen to white noise through headphones for 15 minutes during the dental filling procedure.', 'armGroupLabels': ['White Noise Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Artvin', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Emre ERKAL, PhD', 'role': 'CONTACT', 'email': 'emre.erkal@artvin.edu.tr'}], 'facility': 'Artvin Oral and Dental Health Center', 'geoPoint': {'lat': 41.18161, 'lon': 41.82172}}], 'centralContacts': [{'name': 'Emre ERKAL, PhD', 'role': 'CONTACT', 'email': 'emre.erkal@artvin.edu.tr', 'phone': '+90 5433750709'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMRE ERKAL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'EMRE ERKAL', 'investigatorAffiliation': 'Artvin Coruh University'}}}}