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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04798040
Other study ID # 20012021-2/IV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date October 5, 2021

Study information

Verified date June 2022
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
cold application
To reduce pain, cold application is applied around the drain before the drain is removed.
lavender oil inhalation
To reduce pain, lavender oil is inhaled prior to drain removal.
oxygen administration
To reduce pain, oxygen is inhaled prior to drain removal.

Locations

Country Name City State
Turkey Mugla Sitki Kocman University Mugla Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

References & Publications (27)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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.
Primary 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 Oxygen Saturation (SPO2) before drain removal Before the drain removal oxygen saturation level (SPO2) (percent) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. The researcher measured the oxygen saturation in subcutaneous arterial blood with a "Pulse oximeter" device that is reliable, easy to use, does not require calibration and does not cause pain to the patient in its application. Normal value of oxygen saturation (SpO2) (percent) was accepted as 96-98%. After placing a probe in the periphery (on the patient's finger) by the investigator, the signal received from the periphery and the value on the image screen (monitor) where the pulse wave sample was projected was recorded as oxygen saturation. 15 minutes before the drain removal
Secondary Oxygen Saturation (SPO2) as soon as the drain removal As soon as the drain removal, the oxygen saturation level (SPO2) (percent) of all patients (lavender oil, cold application, oxygen administration and control group) was measured.The researcher measured the oxygen saturation in subcutaneous arterial blood with a "Pulse oximeter" device that is reliable, easy to use, does not require calibration and does not cause pain to the patient in its application. Normal value of oxygen saturation (SpO2) (percent) was accepted as 96-98%. After placing a probe in the periphery (on the patient's finger) by the investigator, the signal received from the periphery and the value on the image screen (monitor) where the pulse wave sample was projected was recorded as oxygen saturation. as soon as the drain removal
Secondary Oxygen Saturation (SPO2) after the drain removal After the drain removal oxygen saturation level (SPO2)(percent) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. The researcher measured the oxygen saturation in subcutaneous arterial blood with a "Pulse oximeter" device that is reliable, easy to use, does not require calibration and does not cause pain to the patient in its application. Normal value of oxygen saturation (SpO2) (percent) was accepted as 96-98%. After placing a probe in the periphery (on the patient's finger) by the investigator, the signal received from the periphery and the value on the image screen (monitor) where the pulse wave sample was projected was recorded as oxygen saturation. 15 minutes after the drain is removed
Secondary Systolic and Diastolic Blood Pressure before the drain removal Before the drain removal blood pressure (mm/Hg) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. Blood Pressure Measurement was performed using a conventional cuffed sphygmomanometer that can measure systolic and diastolic blood pressure, whose reliability was approved according to international standards and calibrated by the company in technical laboratories for certain periods. The cuff of the sphygmomanometer will be inflated to 20 mm / Hg above the systolic pressure by tying it to cover 2/3 of the arm, and the measurement will be carried out by the researcher. 15 minutes before the drain removal
Secondary Systolic and Diastolic Blood Pressure as soon as the drain removal As soon as the drain removal blood pressure (mm/Hg) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. Blood Pressure Measurement was performed using a conventional cuffed sphygmomanometer that can measure systolic and diastolic blood pressure, whose reliability was approved according to international standards and calibrated by the company in technical laboratories for certain periods. The cuff of the sphygmomanometer will be inflated to 20 mm / Hg above the systolic pressure by tying it to cover 2/3 of the arm, and the measurement will be carried out by the researcher. as soon as the drain removal
Secondary Systolic and Diastolic Blood Pressure after the drain removal After the drain removal blood pressure (mm/Hg) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. Blood Pressure Measurement was performed using a conventional cuffed sphygmomanometer that can measure systolic and diastolic blood pressure, whose reliability was approved according to international standards and calibrated by the company in technical laboratories for certain periods. The cuff of the sphygmomanometer will be inflated to 20 mm / Hg above the systolic pressure by tying it to cover 2/3 of the arm, and the measurement will be carried out by the researcher. 15 minutes after the drain is removed
Secondary Pulse rate before the drain removal Before the drain removal pulse rate (min) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. The pulse was obtained by the investigator palpating the superficial arteries (by touching them with the hand) and counting the beats felt for one minute. 60 to 100 beats per minute was considered normal for an adult. 15 minutes before the drain removal
Secondary Pulse rate as soon as the drain removal As soon as the drain removal pulse rate (min) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. The pulse was obtained by the investigator palpating the superficial arteries (by touching them with the hand) and counting the beats felt for one minute. 60 to 100 beats per minute was considered normal for an adult. as soon as the drain removal
Secondary Pulse rate after the drain removal After the drain removal pulse rate (min) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. The pulse was obtained by the investigator palpating the superficial arteries (by touching them with the hand) and counting the beats felt for one minute. 60 to 100 beats per minute was considered normal for an adult. 15 minutes after the drain is removed
Secondary Respiration rate before the drain removal Before the drain removal respiration rate (min) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. Respiration rate was measured by the number of diaphragm movements per minute. For an adult at rest, 12 to 20 per minute was considered normal for respiratory rate. 15 minutes before the drain removal
Secondary Respiration rate as soon as the drain removal As soon as the drain removal respiration rate (min) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. Respiration rate was measured by the number of diaphragm movements per minute. For an adult at rest, 12 to 20 per minute was considered normal for respiratory rate. as soon as the drain removal
Secondary Respiration rate after the drain removal After the drain removal respiration rate (min) of all patients (lavender oil, cold application, oxygen administration and control group) were measured. Respiration rate was measured by the number of diaphragm movements per minute. For an adult at rest, 12 to 20 per minute was considered normal for respiratory rate. 15 minutes after the drain is removed
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