Anxiety Disorder Clinical Trial
Official title:
Can Lavender Oil Inhalation Help to Overcome Dental Anxiety and Pain in Children? A Randomized Clinical Trial
NCT number | NCT04115891 |
Other study ID # | 07 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | September 30, 2019 |
Verified date | October 2019 |
Source | Recep Tayyip Erdogan University Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.
Status | Completed |
Enrollment | 126 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: - being between 6 and 12 years of age - children who are determined as Frankl 2, 3 or 4 - intellectually sufficient to complete the anxiety scale - volunteer to take part in the study - whose parents were willing to participate into the study Exclusion Criteria: - aged under 6 - has cognitive, cooperation (i.ex. Frankl 1) or systemic problems - common allergies or dental pain |
Country | Name | City | State |
---|---|---|---|
Turkey | Nazife Begüm KARAN | Ankara | Merkez |
Turkey | Nazife Begüm KARAN | Ri?ze | Merkez |
Lead Sponsor | Collaborator |
---|---|
Recep Tayyip Erdogan University Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vital Sign Measurements - 1 (sistolic and diastolic blood pressure) | changes in systolic and diastolic blood pressure pre-operatively, intra-operatively, post-operatively | through study completion an average of 9 months | |
Primary | Vital Sign Measurements - 2 (heart rate) | changes in heart rate pre-operatively, intra-operatively, post-operatively | through study completion an average of 9 months | |
Primary | Vital Sign Measurements - 3 (saturation) | changes in saturation pre-operatively, intra-operatively, post-operatively | through study completion an average of 9 months | |
Secondary | Anxiety Scale - Face Image Scale (FIS) | Five cartoon faces symbolized different emotions from very happy to very unhappy. The children chose one face at which they feel most like at that moment. One point is given to most positive face and 5 point is given to most negative face. | through study completion an average of 9 months | |
Secondary | Pain Scale 1 - Face, Legs, Activity, Cry, Consolability (FLACC) | FLACC has five categories of behavior to rate pain as follows; facial expression, leg movement, activity, cry and consolability. The scores of each category are between 0 and 2. The total scores can change from 0 to 10 defined as mild (1-3), moderate (4-6) and severe (7-10). | through study completion an average of 9 months | |
Secondary | Pain Scale 2 - Wong Baker Pain Rating Scales (WBS) | WBS combines pictures and numbers to rate pain. The scale has six faces assigned numerical ratings from 0 'no hurt' to 10 'hurts worst'. Administration of WBS is easy, not time consuming and requires minimal instructions | through study completion an average of 9 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06038721 -
Unified Protocol: Community Connections
|
N/A | |
Not yet recruiting |
NCT03224845 -
Courageous Parents, Courageous Children
|
N/A | |
Completed |
NCT02096783 -
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
|
N/A | |
Completed |
NCT02145429 -
Preventing Depression in Late Life: A Model for Low and Middle Income Countries
|
N/A | |
Completed |
NCT00794456 -
Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
|
Phase 3 | |
Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A | |
Completed |
NCT00252343 -
Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder
|
Phase 3 | |
Not yet recruiting |
NCT05867823 -
OcupApp: Occupational Self-analysis Intervention Through an Mobile Application
|
N/A | |
Recruiting |
NCT04562324 -
Efficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety Disorder
|
N/A | |
Recruiting |
NCT05989451 -
Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders
|
N/A | |
Not yet recruiting |
NCT05488418 -
Clinical Study of Biomarkers of Stress Resilience: Role of ELK1 and GPR56
|
N/A | |
Not yet recruiting |
NCT03608449 -
Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System
|
N/A | |
Completed |
NCT03400397 -
An Effectiveness Study of the Cool Kids Programme
|
N/A | |
Completed |
NCT00025844 -
Fear Conditioning Using Computer-Generated Virtual Reality
|
N/A | |
Completed |
NCT02579928 -
Ketamine Infusion for Adolescent Depression and Anxiety
|
Phase 4 | |
Completed |
NCT02270073 -
The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study
|
N/A | |
Terminated |
NCT03764644 -
Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders
|
N/A | |
Completed |
NCT01425619 -
The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
|
N/A | |
Completed |
NCT01721824 -
The Effect of IPS-MA- A Modified Early Supported Employment Intervention for Individuals With Mood or Anxiety Disorders
|
N/A | |
Completed |
NCT01764789 -
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
|
N/A |