Colonic Disease Clinical Trial
Official title:
The Effect of Lavender Oil Inhalation on Anxiety and Comfort in Patients Undergoing Colonoscopy: A Randomized Controlled, Single-center Study.
NCT number | NCT05540418 |
Other study ID # | 2022/03 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 15, 2022 |
Est. completion date | September 3, 2022 |
Verified date | September 2022 |
Source | Kirsehir Ahi Evran University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim: In this study, it was aimed to determine the effect of lavender oil inhalation on the anxiety and comfort levels of patients who will undergo colonoscopy. Material and Method: In this randomized controlled, prospective study, 73 experimental and 72 control group patients who will experience colonoscopy in a training and research hospital in western Turkey were included. While lavender inhalation was applied to the patients in the experimental group, routine care was applied to the patients in the control group. The short-form state-trait anxiety scale and general comfort scale were used to collect data before and after the procedure. p<0.05 level was considered statistically significant.
Status | Completed |
Enrollment | 145 |
Est. completion date | September 3, 2022 |
Est. primary completion date | August 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 44 Years to 60 Years |
Eligibility | Inclusion Criteria: - over 18 years old, 65 years old and under, - having colonoscopy, - not having the risk of heart failure and cardiogenic shock (class III and IV), - not having a history of asthma, eczema, and allergies to flowers and plants, - not allergic to lavender, - not having communicative/severe hearing or speech impairment, - not using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine and narcotic derivatives - having stable vital signs - individuals who volunteered to participate in research Exclusion Criteria: - individuals who do not meet the inclusion criteria |
Country | Name | City | State |
---|---|---|---|
Turkey | Kirklareli University | Kirklareli | Faculty Of Health Sciences |
Lead Sponsor | Collaborator |
---|---|
Kirsehir Ahi Evran University | Kirklareli University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of the State-Trait Anxiety Inventory scores | State anxiety inventory determines how an individual feels at a certain moment and under certain conditions. The trait anxiety inventory, on the other hand, is defined as the anxiety that an individual feels in his normal life. Each item in the inventory is evaluated between one and four points. High total scores in the inventories indicate a high state anxiety level of the individual. In the inventory, scores above 42 are considered as "high anxiety level". The internal consistency (Cronbach's Alpha) coefficients of this inventory range from 0.83 to 0.92 for the state anxiety inventory.
The State-Trait Anxiety inventory was evaluated 20 minutes before and 20 minutes after colonoscopy in the intervention and control groups. Anxiety level was evaluated with the State-Trait Anxiety inventory before and 20 minutes after lavender oil inhalation in patients in the intervention group. |
Before the colonoscopic procedure - on colonoscopic procedure day | |
Primary | Change of the Overal Comfort Scale | General Comfort Scale: The scale consists of 28 questions and shows the current comfort status of the patient. The score of the scale varies between 28-168. The Cronbach alpha of the 6-point Likert-type scale is 0.82.
The general comfort scale was evaluated 20 minutes before and 20 minutes after colonoscopy in the intervention and control groups. Overall comfort level was assessed before and 20 minutes after lavender oil inhalation in patients in the intervention group. A high score on the scale indicates that the general comfort level of the patients is high. |
Before the colonoscopic procedure - on colonoscopic procedure day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05512026 -
Performance of the Poseidon System for Fluid Management During Water-aided Colonoscopy
|
N/A | |
Recruiting |
NCT05322486 -
Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases
|
||
Completed |
NCT02276768 -
Study on Analgesia of GIC-1001 & GIC-1002 on Visceral Pain, Rectal Sensory Threshold Using the Barostat Method
|
Phase 1 | |
Recruiting |
NCT04693299 -
Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy
|
||
Not yet recruiting |
NCT06271538 -
Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
|
Phase 4 | |
Not yet recruiting |
NCT05391529 -
Patients Decision Making in Choosing Between Colonic Investigation Alternatives
|
||
Recruiting |
NCT05709145 -
Written Recommendation to Improve Adherence in Poor Bowel Preparation
|
N/A | |
Enrolling by invitation |
NCT04765163 -
Research on Operating Handle of Colonoscope
|
||
Completed |
NCT04112654 -
Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
|
N/A | |
Not yet recruiting |
NCT06435377 -
Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions
|
||
Completed |
NCT04487626 -
Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring
|
N/A | |
Not yet recruiting |
NCT05836064 -
GastroBot: Artificial Intelligence Applied to Bowel Preparation
|
N/A | |
Not yet recruiting |
NCT05249335 -
Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly
|
Phase 4 | |
Recruiting |
NCT05249192 -
Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection
|
N/A | |
Recruiting |
NCT06031051 -
Capsule Endoscopy as an Alternative to Colonoscopy
|
N/A | |
Completed |
NCT00604422 -
Evaluation of the PillCamâ„¢ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis
|