Non-malignant Chronic PainRCNMPNCT04786288
Reliving Chronic Non-malignant Pain of Elderly Individuals Using Aromatic Hand Massage
A study testing massage with lavender essential oil mixed in a carrier oil and massage with odourless baby oil in people with Non-malignant Chronic Pain, run by Haben Tesfu Gebreselassie at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study was conducted to determine the effect of hand aromatherapy massage on non-malignant chronic pain. Total of 66 elderly individuals who had visited an algology outpatient polyclinic with a complaint of chronic non-malignant pain for at least three months were randomly assigned to the… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Non-malignant Chronic Pain
- What is being tested?
- massage with lavender essential oil mixed in a carrier oil and massage with odourless baby oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 30 Aug 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients over the age of 65 years and older
- who had chronic non-malignant pain for at least three months
- those who had agreed to participate in research
- those who do not have cognitive impairment and can answer questions
Who cannot join
- patients with dermatological problems on the hand or arm,
- Any swelling or signs of inflammation in the hand or arm,
- those who have neuropathy or loss of sensation in the hand or arm,
- those who have hand deformity,
- those who are allergic to lavender, perfumes or cosmetics,
- those who had undergone Surgery in the last month or so
- those who are diagnosed with Cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege Unversity Algology polyclinic
Izmir, Bornova, 35100
About this study
Official title: The Effect of Aromatherapy Hand Massage on Pain Level and Vital Signs in Elderly People With Chronic Non-malignant Pain
This randomized controlled study was conducted to determine the effect of hand aromatherapy massage on non-malignant chronic pain.
Total of 66 elderly individuals who had visited an algology outpatient polyclinic with a complaint of chronic non-malignant pain for at least three months were randomly assigned to the study. Participants were allocated to three groups and aromatherapy massage was done for those in the intervention group while odourless baby oil was used during the hand massage in the placebo group, those participants in the control group did not receive any type of intervention. Data collection was carried out using Individual Diagnosis Form, Visual Analogue Scale and Brief Pain Inventory. Before and after intervention, data collection forms were filled and pain level and vital signs were evaluated.
Read more
Participants pain severity after aromatherapy decreased by 42.24%. When comparing vital sign pre-post procedure; systolic blood pressure value for the placebo group was significantly lower. Right after intervention, pulse rate was significantly lower in aromatherapy and placebo groups while post intervention body temperature in aromatherapy group was found to be higher and statistically significant.
This study has shown that aromatherapy hand massage is effective on lowering pain level and positively influencing vital signs of elderly individuals with chronic non-malignant pain. Considering these beneficial effects, aromatherapy massage can be used as an independent nursing intervention in elderly individuals who are suffering from chronic pain.
Read the detailed description
This research study was designed as a randomized placebo-controlled clinical trial to examine the effect of aromatherapy hand massage on chronic non-malignant pain and vital signs of elderly individuals. Sample size was determined via G-power statistical analysis with 95% confidence and 80% theoretical power. Initially pilot study was performed with total of 6 elderly patients, 2 individuals for each group. Those elderly patients who visited the polyclinic on Monday were appointed to aromatherapy group (n=22), those who came on Wednesday they were assigned to placebo group (n=22) and those who visited the clinic on Friday were allocated to control group (n=22). Individuals who were included in this research were age 65 and above, must have chronic non-malignant pain for at least three months, should not have cognitive impairment, must be able to answer questions independently and those who have agreed to be part of the study were included in the sample. In the contrary, patients with dermatological problems, swelling, sign of inflammation, neuropathy or loss of sensation and deformity on their hands and/ or arms were excluded from the study and cancer patients and those who had allergic to lavender oil were also excluded.
Data were gathered as patient information form, visual analogue scale (VAS), brief pain inventory and vital signs which were collected by a single researcher via face-to-face interview and hand massage was performed by the same researcher.
In the aromatherapy group written and verbal consent was obtained from participants prior the intervention after that patient information form was filled, pain level was assessed via visual analogue scale (VAS) and brief pain inventory, vital signs were assessed as well. M technique hand massage was done on both hands and arms for 10 minutes using lavender essential oil (12 drops of lavender essential oil mixed in 30 ml of fragrance-free baby oil as a carrier oil) afterwards pain level was re-assessed using usual analogue scale and vital signs were re-evaluated within 10-15 minutes after the completion of the intervention.
In the placebo group written and verbal consent was obtained from participants prior the intervention after that patient information form was filled, pain level was assessed via visual analogue scale (VAS) and brief pain inventory, vital signs were assessed as well. M technique hand massage was done on both hands and arms for 10 minutes using odourless baby oil, afterwards pain level was re-assessed using usual analogue scale and vital signs were re-evaluated within 10-15 minutes after the completion of the intervention.
In the control group, patient information form was filled, pain level was assessed via visual analogue scale (VAS) and brief pain inventory, vital signs were assessed after obtaining verbal and written consent from the elderly participants. No intervention was done by the researcher for this group except routine treatment, within 10-15 minutes pain level was reassessed using VAS and vital signs were re-evaluated.
Application: aromatherapy is a natural and gentle form of treatment that can access the human body through inhaled scent molecules that activate the limbic system, an area in the brain that plays an important role for emotion and behaviour. It can also be applied as a topical massage which gives soothing and relaxing feeling by stimulating the nervous system that regulates heart rate, blood pressure, stress and breathing patterns. On top of all the benefits, easy application, low cost and low side effects are some of the reasons aromatherapy is accepted as complementary and integrative medicine. M technique hand massage is a unique choreographed method that follows certain type of movement, pressure and pace which is custom made for the most fragile patient. Combining aromatherapy with the M technique hand massage, can give satisfactory results, as this massage technique is an extremely soft, comfortable and relaxing massage type that can be applied to even the most fragile patient.
- Conditions
- Non-malignant Chronic Pain
- Being tested
- massage with lavender essential oil mixed in a carrier oil, massage with odourless baby oil
- Keywords
- aromatherapy, elderly, massage, pain, vital signs
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage with lavender essential oil mixed in a carrier oilOther
22 elderly participants received a one session M technique hand massage that lasted 10 minutes for both their hands and arms using 2% lavender essential oil diluted with odourless baby oil (12 drops of lavender essential oil mixed in 30 ml of carrier oil) was used to apply the M technique hand massage
massage with odourless baby oilOther
odourless baby oil was used for the application of one session M technique hand massage on both hands and arms for 10 minutes for the 22 elderly participants.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Experimental | 22 elderly participants received M technique hand massage that lasted for 10 minutes for both their hands and arms using 2% lavender essential oil diluted with odourless baby oil (12 drops of lavender essential oil mixed in 30 ml of carrier oil) was used to apply the hand massage.
Intervention: massage with lavender essential oil mixed in a carrier oil Receives: Other: massage with lavender essential oil mixed in a carrier oil |
| Placebo | Placebo comparator | odourless baby oil was used for the application of the M technique hand massage on both hands and arms for 10 minutes for the 22 elderly participants.
Intervention: other: massage with no fragrance baby oil Receives: Other: massage with odourless baby oil |
| Control | No intervention | Participants in this group didn't receive any type of intervention from the researcher except the routine hospital management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The visual analogue scale (VAS) is a subjective measure for the level of pain consisting of 10cm horizontal or vertical line, with "0" indicating no pain at one end while "10" indicates very severe pain at the other end. Patients mark the point that corresponds to the pain he/she was experiencing during the interview. The scale was used in this study to evaluate level of chronic pain. This scale is a very sensitive method that helps to evaluate pharmacological and non-pharmacological treatments that reduce pain (Uyar \& Yıldırım, 2010).
Measured: 15 minutes
Brief pain inventor
Wisconsin Short Pain inventory was developed to evaluate pain status of individuals with cancer or chronic diseases. It consists of 15 items and each item takes a value between 0-10. The lowest score obtained from the brief pain inventory indicates that there is no pain in the last 24 hours, 1-3 points indicate mild pain in the last 24 hours, 4-7 points indicate moderate pain in the last 24 hours, and 8-10 points indicate severe pain in the last 24 hours. The validity and reliability study of the brief pain inventory for patients with chronic non-malignant pain in Turkey was conducted by Yıldırım et al. (2019).
Measured: base line
Patient information form
The individual identification form was created by the researchers in the light of information collected from the literature. It was divided into 3 different parts; the first part contained sociodemographic characteristics such as age, gender, educational status, occupation, social security, marital status, and number of children. The second part was regarding health-related characteristics such as duration of chronic pain diagnosis whether or not it had been treated, what treatment modality was applied, how long the pain complaint had lasted, the presence of other accompanying illnesses, and general state of health.
Measured: base line
Blood Pressure
Systolic and diastolic blood pressure was measured with Omron digital arm meter sphygmomanometer.
Measured: 15 minutes
Pulse Rate
Puls rate was counted and evaluated for one whole minute.
Measured: 15 minutes
Respiratory Rate
Respiratory rate was counted and evaluated for one whole minute.
Measured: 15 minutes
Body Temperature
Body temperature was recorded using infrared thermometer.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 May 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-malignant Chronic PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- simple and stratified randomization method (experiment, control and placebo group x pre-test post-test)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haben Tesfu Gebreselassie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haben Tesfu Gebreselassie, Ege University
- Investigators
- Meltem Uyar, Professor, Study director, Ege Unversityyasemin Yildirim, Professor, Study director, Ege UnversityHaben Tesfu Gebreselassie, Study director, Ege Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786288
- Sponsor's protocol ID
- 19-4.1T/26
- Acronym
- RCNMP
- Status last verified
- Feb 2021
- First submitted
- 28 Feb 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no planning
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Hand Massage on Pain Level and Vital Signs in Elderly People With Chronic Non-malignant Pain
- ClinicalTrials.gov ID
- NCT04786288
- Acronym / sponsor ID
- RCNMP / 19-4.1T/26
- Conditions
- Non-malignant Chronic Pain
- Keywords
- aromatherapy, elderly, massage, pain, vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Haben Tesfu GebreselassieUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 8 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 randomized controlled study was conducted to determine the effect of hand aromatherapy massage on non-malignant chronic pain.
Total of 66 elderly individuals who had visited an algology outpatient polyclinic with a complaint of chronic non-malignant pain for at least three months were randomly assigned to the study. Participants were allocated to three groups and aromatherapy massage was done for those in the intervention group while odourless baby oil was used during the hand massage in the placebo group, those participants in the control group did not receive any type of intervention. Data collection was carried out using Individual Diagnosis Form, Visual Analogue Scale and Brief Pain Inventory. Before and after intervention, data collection forms were filled and pain level and vital signs were evaluated.
Participants pain severity after aromatherapy decreased by 42.24%. When comparing vital sign pre-post procedure; systolic blood pressure value for the placebo group was significantly lower. Right after intervention, pulse rate was significantly lower in aromatherapy and placebo groups while post intervention body temperature in aromatherapy group was found to be higher and statistically significant.
This study has shown that aromatherapy hand massage is effective on lowering pain level and positively influencing vital signs of elderly individuals with chronic non-malignant pain. Considering these beneficial effects, aromatherapy massage can be used as an independent nursing intervention in elderly individuals who are suffering from chronic pain.
Detailed description
This research study was designed as a randomized placebo-controlled clinical trial to examine the effect of aromatherapy hand massage on chronic non-malignant pain and vital signs of elderly individuals. Sample size was determined via G-power statistical analysis with 95% confidence and 80% theoretical power. Initially pilot study was performed with total of 6 elderly patients, 2 individuals for each group. Those elderly patients who visited the polyclinic on Monday were appointed to aromatherapy group (n=22), those who came on Wednesday they were assigned to placebo group (n=22) and those who visited the clinic on Friday were allocated to control group (n=22). Individuals who were included in this research were age 65 and above, must have chronic non-malignant pain for at least three months, should not have cognitive impairment, must be able to answer questions independently and those who have agreed to be part of the study were included in the sample. In the contrary, patients with dermatological problems, swelling, sign of inflammation, neuropathy or loss of sensation and deformity on their hands and/ or arms were excluded from the study and cancer patients and those who had allergic to lavender oil were also excluded.
Data were gathered as patient information form, visual analogue scale (VAS), brief pain inventory and vital signs which were collected by a single researcher via face-to-face interview and hand massage was performed by the same researcher.
In the aromatherapy group written and verbal consent was obtained from participants prior the intervention after that patient information form was filled, pain level was assessed via visual analogue scale (VAS) and brief pain inventory, vital signs were assessed as well. M technique hand massage was done on both hands and arms for 10 minutes using lavender essential oil (12 drops of lavender essential oil mixed in 30 ml of fragrance-free baby oil as a carrier oil) afterwards pain level was re-assessed using usual analogue scale and vital signs were re-evaluated within 10-15 minutes after the completion of the intervention.
In the placebo group written and verbal consent was obtained from participants prior the intervention after that patient information form was filled, pain level was assessed via visual analogue scale (VAS) and brief pain inventory, vital signs were assessed as well. M technique hand massage was done on both hands and arms for 10 minutes using odourless baby oil, afterwards pain level was re-assessed using usual analogue scale and vital signs were re-evaluated within 10-15 minutes after the completion of the intervention.
In the control group, patient information form was filled, pain level was assessed via visual analogue scale (VAS) and brief pain inventory, vital signs were assessed after obtaining verbal and written consent from the elderly participants. No intervention was done by the researcher for this group except routine treatment, within 10-15 minutes pain level was reassessed using VAS and vital signs were re-evaluated.
Application: aromatherapy is a natural and gentle form of treatment that can access the human body through inhaled scent molecules that activate the limbic system, an area in the brain that plays an important role for emotion and behaviour. It can also be applied as a topical massage which gives soothing and relaxing feeling by stimulating the nervous system that regulates heart rate, blood pressure, stress and breathing patterns. On top of all the benefits, easy application, low cost and low side effects are some of the reasons aromatherapy is accepted as complementary and integrative medicine. M technique hand massage is a unique choreographed method that follows certain type of movement, pressure and pace which is custom made for the most fragile patient. Combining aromatherapy with the M technique hand massage, can give satisfactory results, as this massage technique is an extremely soft, comfortable and relaxing massage type that can be applied to even the most fragile patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- simple and stratified randomization method (experiment, control and placebo group x pre-test post-test)
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Other: massage with lavender essential oil mixed in a carrier oil22 elderly participants received M technique hand massage that lasted for 10 minutes for both their hands and arms using 2% lavender essential oil diluted with odourless baby oil (12 drops of lavender essential oil mixed in 30 ml of carrier oil) was used to apply the hand massage. Intervention: massage with lavender essential oil mixed in a carrier oil |
| Placebo | Placebo comparator | Other: massage with odourless baby oilodourless baby oil was used for the application of the M technique hand massage on both hands and arms for 10 minutes for the 22 elderly participants. Intervention: other: massage with no fragrance baby oil |
| Control | No intervention | –Participants in this group didn't receive any type of intervention from the researcher except the routine hospital management. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- patients over the age of 65 years and older
- who had chronic non-malignant pain for at least three months
- those who had agreed to participate in research
- those who do not have cognitive impairment and can answer questions
Key exclusion criteria (7 listed)
- patients with dermatological problems on the hand or arm,
- Any swelling or signs of inflammation in the hand or arm,
- those who have neuropathy or loss of sensation in the hand or arm,
- those who have hand deformity,
- those who are allergic to lavender, perfumes or cosmetics,
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 |
|---|---|---|
| massage with lavender essential oil mixed in a carrier oil22 elderly participants received a one session M technique hand massage that lasted 10 minutes for both their hands and arms using 2% lavender essential oil diluted with odourless baby oil (12 drops of lavender essential oil mixed in 30 ml of carrier oil) was used to apply the M technique hand massage | Other | Aromatherapy |
| massage with odourless baby oilodourless baby oil was used for the application of one session M technique hand massage on both hands and arms for 10 minutes for the 22 elderly participants. | Other | Placebo |
Primary outcome
Visual Analogue Scale
Time frame: 15 minutes
The visual analogue scale (VAS) is a subjective measure for the level of pain consisting of 10cm horizontal or vertical line, with "0" indicating no pain at one end while "10" indicates very severe pain at the other end. Patients mark the point that corresponds to the pain he/she was experiencing during the interview. The scale was used in this study to evaluate level of chronic pain. This scale is a very sensitive method that helps to evaluate pharmacological and non-pharmacological treatments that reduce pain (Uyar \& Yıldırım, 2010).
Brief pain inventor
Time frame: base line
Wisconsin Short Pain inventory was developed to evaluate pain status of individuals with cancer or chronic diseases. It consists of 15 items and each item takes a value between 0-10. The lowest score obtained from the brief pain inventory indicates that there is no pain in the last 24 hours, 1-3 points indicate mild pain in the last 24 hours, 4-7 points indicate moderate pain in the last 24 hours, and 8-10 points indicate severe pain in the last 24 hours. The validity and reliability study of the brief pain inventory for patients with chronic non-malignant pain in Turkey was conducted by Yıldırım et al. (2019).
Patient information form
Time frame: base line
The individual identification form was created by the researchers in the light of information collected from the literature. It was divided into 3 different parts; the first part contained sociodemographic characteristics such as age, gender, educational status, occupation, social security, marital status, and number of children. The second part was regarding health-related characteristics such as duration of chronic pain diagnosis whether or not it had been treated, what treatment modality was applied, how long the pain complaint had lasted, the presence of other accompanying illnesses, and general state of health.
Blood Pressure
Time frame: 15 minutes
Systolic and diastolic blood pressure was measured with Omron digital arm meter sphygmomanometer.
Pulse Rate
Time frame: 15 minutes
Puls rate was counted and evaluated for one whole minute.
Respiratory Rate
Time frame: 15 minutes
Respiratory rate was counted and evaluated for one whole minute.
Body Temperature
Time frame: 15 minutes
Body temperature was recorded using infrared thermometer.
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 9 Mar 2021.
- Individual participant dataSharing planned: No. no planning
Related trials for Non-malignant Chronic Pain
Recruiting
Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity
Chronic Pain
Active, not recruiting
Effectiveness of Acceptance and Commitment Therapy for Chronic Non-Malignant Pain: A Randomized Controlled Trial
Chronic Non-Malignant Pain (Chronic Musculoskeletal Pain, Chronic Widespread Pain)
Enrolling by invitation
Collaboratory Treatment Pathway for Chronic Pain Patients.
Chronic Pain, Chronic Pain Syndrome
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.
Meltem Uyar, Professor study director
Ege Unversity
yasemin Yildirim, Professor study director
Ege Unversity
Haben Tesfu Gebreselassie study director
Ege Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage with lavender essential oil mixed in a carrier oil and massage with odourless baby oil in people with Non-malignant Chronic Pain, run by Haben Tesfu Gebreselassie 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 4 inclusion and 7 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 9 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (time frame: 15 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2021.