Major Abdominal SurgeryNCT04798040
Effects of Lavender Aromatherapy and Cold Application on Pain During Drain Removal
A study testing cold application, lavender oil inhalation and oxygen administration in people with Major Abdominal Surgery, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- cold application, lavender oil inhalation and oxygen administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 5 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman University
Muğla, Muğla, 48000
About this study
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.
Read the detailed description
It is common practice to place a drainage tube in the peritoneal cavity after abdominal surgery. Although drain application is an important initiative, the severe pain caused during the removal process should also be controlled . Pain and discomfort continue to be a problem during the removal of surgical silicone drains. In the literature, patients describe silicone drain removal as a very painful procedure. Analgesics applied during drain removal are among the commonly used methods in the treatment of acute pain . However, the fact that the response of the patient to pharmacological treatment is variable and the pain cannot be completely controlled with these agents necessitates the use of non-pharmacological methods in addition to pharmacological agents in the control of severe pain.
One of the non-pharmacological methods used in pain control is cold application. Cold application reduces the oxygen and nutrient requirement of tissues by slowing down metabolism, and eliminates pressure and tension on nerve endings by limiting inflammation, spasm and edema; It creates an analgesic effect by slowing or blocking the conduction velocity of peripheral nerves. In addition, it increases the release of endogenous opioids by stimulating the touch receptors with the gate-control mechanism, thereby reducing pain.
Aromatherapy using essential oils is now used by many healthcare professionals in the UK, Australia, Canada, New Zealand, Germany and Switzerland as a part of patient care to reduce pain and stress. When the effects of essential oils used for this purpose are examined; It is seen that it accelerates blood and lymph circulation, relieves muscle spasm and has calming effects. It is reported that these effects of essential oils are both absorbed from the skin and stimulated the sense of smell. In the literature, it is emphasized that some known or unknown analgesic components in oils affect the release of substances such as dopamine, endorphin, noradrenaline and serotonin in the brain stem, and that they have analgesic properties that are said to be formed as a result.
The physiological and psychological effects of aromatherapy have long been known in complementary medicine. Lavender oil has been associated with its mood enhancing and analgesic properties in healthy subjects and experimental nociception. This therapy has been successfully used in clinical settings to alleviate a wide variety of pain, such as dressing change in the intensive care unit, palliative care, for the control of labor pain, and chronic pain. There are numerous studies describing the use of this therapy to relieve anxiety and improve mood. Limited studies have shown that aromatherapy is beneficial for women who give birth and reduces the need for pain medication.
Considering the potential positive effect of lavender oil on the physiological and psychological state of the patient and the positive effect of cold application on the pain mechanism, our study was planned to determine the effectiveness of lavender aromatherapy and cold application in controlling the pain that occurs during the drain removal process.
- Conditions
- Major Abdominal Surgery
- Being tested
- cold application, lavender oil inhalation, oxygen administration
- Keywords
- lavender oil, aromatherapy, cold application, pain, nursing care, drain removal
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold applicationOther
To reduce pain, cold application is applied around the drain before the drain is removed.
lavender oil inhalationOther
To reduce pain, lavender oil is inhaled prior to drain removal.
oxygen administrationOther
To reduce pain, oxygen is inhaled prior to drain removal.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: oxygen administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 15 minutes after the drain is removed
Secondary outcomes (12)
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.
Measured: 15 minutes before the drain removal
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.
Measured: as soon as the drain removal
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.
Measured: 15 minutes after the drain is removed
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.
Measured: 15 minutes before the drain removal
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.
Measured: as soon as the drain removal
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.
Measured: 15 minutes after the drain is removed
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.
Measured: 15 minutes before the drain removal
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.
Measured: as soon as the drain removal
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.
Measured: 15 minutes after the drain is removed
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.
Measured: 15 minutes before the drain removal
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.
Measured: as soon as the drain removal
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.
Measured: 15 minutes after the drain is removed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Sep 2021
- Primary completion30 Sep 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile Celebi, Muğla Sıtkı Koçman University
- Investigators
- Murat Urkan, Assoc.Prof., Principal investigator, Mugla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798040
- Sponsor's protocol ID
- 20012021-2/IV
- Status last verified
- Jun 2022
- First submitted
- 8 Mar 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arıoğlu, B. (2012). The effect of progressive muscle relaxation exercise on pain before chest tube removal. Master's thesis, Çukurova University, Adana.
Demir Y, Khorshid L. The effect of cold application in combination with standard analgesic administration on pain and anxiety during chest tube removal: a single-blinded, randomized, double-controlled study. Pain Manag Nurs. 2010 Sep;11(3):186-96. doi: 10.1016/j.pmn.2009.09.002. Epub 2010 May 31.
PubMed 20728068Tucci G, Amorese V, Romanini E. Closed suction drainage after orthopedic surgery: evidence versus practice. J Orthop Traumatol. 2006; 7: 29-32.
Joshi VS, Chauhan S, Kiran U, Bisoi AK, Kapoor PM. Comparison of analgesic efficacy of fentanyl and sufentanil for chest tube removal after cardiac surgery. Ann Card Anaesth. 2007 Jan;10(1):42-5. doi: 10.4103/0971-9784.37923.
PubMed 17455407Hood BS, Henderson W, Pasero C. Chest tube removal: an expanded role for the bedside nurse. J Perianesth Nurs. 2014 Feb;29(1):53-9. doi: 10.1016/j.jopan.2013.11.001. No abstract available.
PubMed 24461283Tercan, B. (2015). Nurses' knowledge and application of non-drug methods in pain management. Master's thesis, İnönü University, Malatya.
Hsieh LY, Chen YR, Lu MC. Efficacy of cold application on pain during chest tube removal: a randomized controlled trial: A CONSORT-compliant article. Medicine (Baltimore). 2017 Nov;96(46):e8642. doi: 10.1097/MD.0000000000008642.
PubMed 29145288Ertug N, Ulker S. The effect of cold application on pain due to chest tube removal. J Clin Nurs. 2012 Mar;21(5-6):784-90. doi: 10.1111/j.1365-2702.2011.03955.x. Epub 2011 Nov 15.
PubMed 22082021Özveren, H. (2011). Non-pharmacological methods in pain control. Faculty of Health Sciences Journal of Nursing, 18 (1), 83-92.
Gorji HM, Nesami BM, Ayyasi M, Ghafari R, Yazdani J. Comparison of Ice Packs Application and Relaxation Therapy in Pain Reduction during Chest Tube Removal Following Cardiac Surgery. N Am J Med Sci. 2014 Jan;6(1):19-24. doi: 10.4103/1947-2714.125857.
PubMed 24678472Gül, A., Eti Aslan, F. (2010). Evidence-Based Approach to Pain Control; Massage and Aromatherapy. Turkey Clinical J Nurs Sci 2012; 4 (1): 30-6
Yip YB, Tam AC. An experimental study on the effectiveness of massage with aromatic ginger and orange essential oil for moderate-to-severe knee pain among the elderly in Hong Kong. Complement Ther Med. 2008 Jun;16(3):131-8. doi: 10.1016/j.ctim.2007.12.003. Epub 2008 Mar 4.
PubMed 18534325Maddocks-Jennings W, Wilkinson JM. Aromatherapy practice in nursing: literature review. J Adv Nurs. 2004 Oct;48(1):93-103. doi: 10.1111/j.1365-2648.2004.03172.x.
PubMed 15347415Steflitsch W, Steflitsch M. Clinical aromatherapy. Journal of Men's Health 2008; 5 (1): 74-85.
Dunning T, James K. Complementary therapies in action--education and outcomes. Complement Ther Nurs Midwifery. 2001 Nov;7(4):188-95. doi: 10.1054/ctnm.2001.0575.
PubMed 11855801
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lavender Aromatherapy and Cold Application on Pain During Drain Removal
- ClinicalTrials.gov ID
- NCT04798040
- Acronym / sponsor ID
- 20012021-2/IV
- Conditions
- Major Abdominal Surgery
- Keywords
- lavender oil, aromatherapy, cold application, pain, nursing care, drain removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is common practice to place a drainage tube in the peritoneal cavity after abdominal surgery. Although drain application is an important initiative, the severe pain caused during the removal process should also be controlled . Pain and discomfort continue to be a problem during the removal of surgical silicone drains. In the literature, patients describe silicone drain removal as a very painful procedure. Analgesics applied during drain removal are among the commonly used methods in the treatment of acute pain . However, the fact that the response of the patient to pharmacological treatment is variable and the pain cannot be completely controlled with these agents necessitates the use of non-pharmacological methods in addition to pharmacological agents in the control of severe pain.
One of the non-pharmacological methods used in pain control is cold application. Cold application reduces the oxygen and nutrient requirement of tissues by slowing down metabolism, and eliminates pressure and tension on nerve endings by limiting inflammation, spasm and edema; It creates an analgesic effect by slowing or blocking the conduction velocity of peripheral nerves. In addition, it increases the release of endogenous opioids by stimulating the touch receptors with the gate-control mechanism, thereby reducing pain.
Aromatherapy using essential oils is now used by many healthcare professionals in the UK, Australia, Canada, New Zealand, Germany and Switzerland as a part of patient care to reduce pain and stress. When the effects of essential oils used for this purpose are examined; It is seen that it accelerates blood and lymph circulation, relieves muscle spasm and has calming effects. It is reported that these effects of essential oils are both absorbed from the skin and stimulated the sense of smell. In the literature, it is emphasized that some known or unknown analgesic components in oils affect the release of substances such as dopamine, endorphin, noradrenaline and serotonin in the brain stem, and that they have analgesic properties that are said to be formed as a result.
The physiological and psychological effects of aromatherapy have long been known in complementary medicine. Lavender oil has been associated with its mood enhancing and analgesic properties in healthy subjects and experimental nociception. This therapy has been successfully used in clinical settings to alleviate a wide variety of pain, such as dressing change in the intensive care unit, palliative care, for the control of labor pain, and chronic pain. There are numerous studies describing the use of this therapy to relieve anxiety and improve mood. Limited studies have shown that aromatherapy is beneficial for women who give birth and reduces the need for pain medication.
Considering the potential positive effect of lavender oil on the physiological and psychological state of the patient and the positive effect of cold application on the pain mechanism, our study was planned to determine the effectiveness of lavender aromatherapy and cold application in controlling the pain that occurs during the drain removal process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: cold applicationThe 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. |
| Lavender oil group | Experimental | Other: lavender oil inhalationAll 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. |
| Oxygen administration | Experimental | Other: oxygen administrationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold applicationTo reduce pain, cold application is applied around the drain before the drain is removed. | Other | Cold application group |
| lavender oil inhalationTo reduce pain, lavender oil is inhaled prior to drain removal. | Other | Lavender oil group |
| oxygen administrationTo reduce pain, oxygen is inhaled prior to drain removal. | Other | Oxygen administration |
Primary outcome
Pain level before the drain removal
Time frame: 15 minutes 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.
Pain level as soon as the drain removal
Time frame: as soon as the drain is removed.
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.
Pain level after drain removal
Time frame: 15 minutes after the drain is removed
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.
12 secondary outcomes
Oxygen Saturation (SPO2) before drain removal
Time frame: 15 minutes before the drain removal
Oxygen Saturation (SPO2) as soon as the drain removal
Time frame: as soon as the drain removal
Oxygen Saturation (SPO2) after the drain removal
Time frame: 15 minutes after the drain is removed
Systolic and Diastolic Blood Pressure before the drain removal
Time frame: 15 minutes before the drain removal
Systolic and Diastolic Blood Pressure as soon as the drain removal
Time frame: as soon as the drain removal
Systolic and Diastolic Blood Pressure after the drain removal
Time frame: 15 minutes after the drain is removed
Pulse rate before the drain removal
Time frame: 15 minutes before the drain removal
Pulse rate as soon as the drain removal
Time frame: as soon as the drain removal
Pulse rate after the drain removal
Time frame: 15 minutes after the drain is removed
Respiration rate before the drain removal
Time frame: 15 minutes before the drain removal
Respiration rate as soon as the drain removal
Time frame: as soon as the drain removal
Respiration rate after the drain removal
Time frame: 15 minutes after the drain is removed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- BackgroundArıoğlu, B. (2012). The effect of progressive muscle relaxation exercise on pain before chest tube removal. Master's thesis, Çukurova University, Adana.
- Background: PubMed 20728068Demir Y, Khorshid L. The effect of cold application in combination with standard analgesic administration on pain and anxiety during chest tube removal: a single-blinded, randomized, double-controlled study. Pain Manag Nurs. 2010 Sep;11(3):186-96. doi: 10.1016/j.pmn.2009.09.002. Epub 2010 May 31.
- BackgroundTucci G, Amorese V, Romanini E. Closed suction drainage after orthopedic surgery: evidence versus practice. J Orthop Traumatol. 2006; 7: 29-32.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Urkan, Assoc.Prof. principal investigator
Mugla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold application, lavender oil inhalation and oxygen administration in people with Major Abdominal Surgery, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level before the drain removal (time frame: 15 minutes before the drain removal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798040, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.