Effects of Lavender Aromatherapy and Cold Application on Pain During Drain Removal

NCT04798040 | Completed DMC

• 1 other identifier: 20012021-2/IV
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of lavender aromatherapy and cold application on pain during drain removal. The investigators hypothesize that there is no difference in pain prevention between lavender oil inhalation and local cold application.

Conditions

Major Abdominal Surgery

Keywords

lavender oil; aromatherapy; cold application; pain; nursing care; drain removal

Outcome Measures

Primary Outcomes (3)

• Pain level before the drain removal

  Pain scores of all patients (lavender oil, cold application, oxygen administration and control group) before removal of the drain were evaluated using the Numerical Rating Scale (NRS). The Numeric Rating Scale is used to digitize the level of pain that cannot be measured numerically. In this scale, patients are asked to describe their pain by numbers, with "0" for painlessness and "10" for the highest unbearable pain. According to this scoring system, less than 3 points indicate mild pain, 3-6 points indicate moderate pain, and more than 6 points indicate severe pain.

  15 minutes before the drain removal

• Pain level as soon as the drain removal

  As soon as the drain was removed, the pain scores of all patients (lavender oil, cold application, oxygen administration and control group) were evaluated using the Numerical Rating Scale (NRS). The Numeric Rating Scale is used to digitize the level of pain that cannot be measured numerically. In this scale, patients are asked to describe their pain by numbers, with "0" for painlessness and "10" for the highest unbearable pain. According to this scoring system, less than 3 points indicate mild pain, 3-6 points indicate moderate pain, and more than 6 points indicate severe pain.

  as soon as the drain is removed.

• Pain level after drain removal

  After the drain was removed, the pain scores of all patients (lavender oil, cold application, oxygen administration and control group) evaluated using the Numerical Rating Scale (NRS). The Numeric Rating Scale is used to digitize the level of pain that cannot be measured numerically. In this scale, patients are asked to describe their pain by numbers, with "0" for painlessness and "10" for the highest unbearable pain. According to this scoring system, less than 3 points indicate mild pain, 3-6 points indicate moderate pain, and more than 6 points indicate severe pain.

  15 minutes after the drain is removed

Secondary Outcomes (12)

• Oxygen Saturation (SPO2) before drain removal

  15 minutes before the drain removal

• Oxygen Saturation (SPO2) as soon as the drain removal

  as soon as the drain removal

• Oxygen Saturation (SPO2) after the drain removal

  15 minutes after the drain is removed

• Systolic and Diastolic Blood Pressure before the drain removal

  15 minutes before the drain removal

• Systolic and Diastolic Blood Pressure as soon as the drain removal

  as soon as the drain removal

Study Arms (4)

Control group

NO INTERVENTION

Routine treatment and nursing care of the clinic will be applied to the patients without any application. Routine interventions applied to the control group during silicone drain removal in the clinic: 1. The patient will be informed about the procedure. 2. The consent of the patient who agrees to participate in the study will be obtained. 3. The patient will mark the pain he feels due to the silicone drain on the Numeric Rating Scale . 4. The patient will mark the pain again from the Numeric Rating Scale immediately after the procedure. 5. The patient will fill the Numeric Rating Scale 15 minutes after the removal of the silicone drain.

Cold application group

EXPERIMENTAL

The patient will mark the pain he feels due to the silicone drain on the Numeric Rating Scale. A gel pad with a temperature of -10 ° C and a homogeneous distribution when cooled will be placed so that the patient is in full contact with the silicone drain.Since the skin temperature must fall below 13.6 ° C for cold application to have a local analgesic effect, the application will be terminated when the patient's skin temperature is 13.6 ° C by measuring every one minute during the cold application and the physician will be informed that the patient is ready.The patient will mark the pain again from the Numeric Rating Scale immediately after the procedure. The patient will fill the Numeric Rating Scale15 minutes after the removal of the silicone drain.

Other: cold application

Lavender oil group

EXPERIMENTAL

All patients who accept the study will be tested for lavender oil before the procedure to exclude sensitivity to lavender. Patients in the lavender group will be given oxygen with a lavender oil covered face mask 15 minutes before the silicone drain is removed. Two drops of 2% lavender oil will be applied with a cotton swab inside the oxygen face mask. The patient will mark the pain he feels due to the silicone drain on the Numeric Rating Scale.The patient will mark the pain again from the Numeric Rating Scale immediately after the procedure.The patient will fill the Numeric Rating Scale 15 minutes after the removal of the silicone drain.

Other: lavender oil inhalation

Oxygen administration

EXPERIMENTAL

The patient will be informed about the procedure. Consent of the patient who agrees to participate in the study will be obtained. Patients in the oxygen administration group will be given 2 lt/min oxygen with a face mask 15 minutes before the silicone drain is removed. The patient will mark the pain he feels due to the silicone drain on Numeric Rating Scale. The patient will re-mark the pain from Numeric Rating Scale immediately after the procedure. The patient will fill the Numeric Rating Scale 15 minutes after the removal of the silicone drain. Before the procedure, as soon as the procedure is over and 15 minutes after the procedure, the patient's vital signs will be measured.

Other: oxygen administration

Interventions

cold application OTHER

To reduce pain, cold application is applied around the drain before the drain is removed.

Cold application group

lavender oil inhalation OTHER

To reduce pain, lavender oil is inhaled prior to drain removal.

Lavender oil group

oxygen administration OTHER

To reduce pain, oxygen is inhaled prior to drain removal.

Oxygen administration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-80,
• Being conscious, oriented and cooperative,
• Can speak and understand Turkish,
• After the surgery with silicone drains
• General condition stable,
• Patients who received written and verbal consent to participate in the study will be included.

You may not qualify if:

• Patients with asthma, bronchitis, chronic obstructive pulmonary disease
• Patients with contact dermatitis against cosmetic fragrances
• Patients who are pregnant
• Patients with poor general condition
• Oriented, non-cooperative patients
• Patients whose consent is not taken will be excluded

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sitki Kocman University

Muğla, Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (27)

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MeSH Terms

Conditions

Pain

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Murat Urkan, Assoc.Prof.

  Mugla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: September 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 5, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)