Clinical trial NCT04786288: Reliving Chronic Non-malignant Pain of Elderly Individuals Using Aromatic Hand Massage
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
Overall status: COMPLETED
Phase: NA
Conditions: Non-malignant Chronic Pain
Keywords: aromatherapy
elderly
massage
pain
vital signs
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: simple and stratified randomization method (experiment, control and placebo group x pre-test post-test)
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 15 minutes
measure: Brief pain inventor
timeFrame: base line
measure: Patient information form
timeFrame: base line
measure: Blood Pressure
timeFrame: 15 minutes
measure: Pulse Rate
timeFrame: 15 minutes
measure: Respiratory Rate
timeFrame: 15 minutes
measure: Body Temperature
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege Unversity Algology polyclinic
state: Bornova
Study officials:
affiliation: Ege Unversity
name: Meltem Uyar, Professor
role: STUDY_DIRECTOR
affiliation: Ege Unversity
name: yasemin Yildirim, Professor
role: STUDY_DIRECTOR
affiliation: Ege Unversity
name: Haben Tesfu Gebreselassie
role: STUDY_DIRECTOR
References: