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Reliving Chronic Non-malignant Pain of Elderly Individuals Using Aromatic Hand Massage (RCNMP)

Primary Purpose

Non-malignant Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
massage with lavender essential oil mixed in a carrier oil
massage with odourless baby oil
Sponsored by
Haben Tesfu Gebreselassie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-malignant Chronic Pain focused on measuring aromatherapy, elderly, massage, pain, vital signs

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ege Unversity Algology polyclinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Aromatherapy

Placebo

Control

Arm Description

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

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

Participants in this group didn't receive any type of intervention from the researcher except the routine hospital management.

Outcomes

Primary Outcome Measures

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).
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).
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.
Blood Pressure
Systolic and diastolic blood pressure was measured with Omron digital arm meter sphygmomanometer.
Pulse Rate
Puls rate was counted and evaluated for one whole minute.
Respiratory Rate
Respiratory rate was counted and evaluated for one whole minute.
Body Temperature
Body temperature was recorded using infrared thermometer.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2021
Last Updated
March 6, 2021
Sponsor
Haben Tesfu Gebreselassie
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1. Study Identification

Unique Protocol Identification Number
NCT04786288
Brief Title
Reliving Chronic Non-malignant Pain of Elderly Individuals Using Aromatic Hand Massage
Acronym
RCNMP
Official Title
The Effect of Aromatherapy Hand Massage on Pain Level and Vital Signs in Elderly People With Chronic Non-malignant Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haben Tesfu Gebreselassie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-malignant Chronic Pain
Keywords
aromatherapy, elderly, massage, pain, vital signs

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
simple and stratified randomization method (experiment, control and placebo group x pre-test post-test)
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aromatherapy
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group didn't receive any type of intervention from the researcher except the routine hospital management.
Intervention Type
Other
Intervention Name(s)
massage with lavender essential oil mixed in a carrier oil
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
massage with odourless baby oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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).
Time Frame
15 minutes
Title
Brief pain inventor
Description
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).
Time Frame
base line
Title
Patient information form
Description
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.
Time Frame
base line
Title
Blood Pressure
Description
Systolic and diastolic blood pressure was measured with Omron digital arm meter sphygmomanometer.
Time Frame
15 minutes
Title
Pulse Rate
Description
Puls rate was counted and evaluated for one whole minute.
Time Frame
15 minutes
Title
Respiratory Rate
Description
Respiratory rate was counted and evaluated for one whole minute.
Time Frame
15 minutes
Title
Body Temperature
Description
Body temperature was recorded using infrared thermometer.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Uyar, Professor
Organizational Affiliation
Ege Unversity
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
yasemin Yildirim, Professor
Organizational Affiliation
Ege Unversity
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Haben Tesfu Gebreselassie
Organizational Affiliation
Ege Unversity
Official's Role
Study Director
Facility Information:
Facility Name
Ege Unversity Algology polyclinic
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no planning

Learn more about this trial

Reliving Chronic Non-malignant Pain of Elderly Individuals Using Aromatic Hand Massage

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