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

NCT04786288 | Completed

• 1 other identifier: 19-4.1T/26
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-malignant Chronic Pain

Keywords

aromatherapy; elderly; massage; pain; vital signs

Outcome Measures

Primary Outcomes (7)

• 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).

  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).

  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.

  base line

• Blood Pressure

  Systolic and diastolic blood pressure was measured with Omron digital arm meter sphygmomanometer.

  15 minutes

• Pulse Rate

  Puls rate was counted and evaluated for one whole minute.

  15 minutes

• Respiratory Rate

  Respiratory rate was counted and evaluated for one whole minute.

  15 minutes

• Body Temperature

  Body temperature was recorded using infrared thermometer.

  15 minutes

Study Arms (3)

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

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

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.

Interventions

massage with lavender essential oil mixed in a carrier oil OTHER

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

Aromatherapy

massage with odourless baby oil OTHER

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.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haben Tesfu Gebreselassie: lead

Study Sites (1)

Ege Unversity Algology polyclinic

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Meltem Uyar, Professor

  Ege Unversity

  STUDY DIRECTOR

• yasemin Yildirim, Professor

  Ege Unversity

  STUDY DIRECTOR

• Haben Tesfu Gebreselassie

  Ege Unversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: simple and stratified randomization method (experiment, control and placebo group x pre-test post-test)

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 8, 2021
• Study Start: May 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: March 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)