Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05113992 |
| Other study ID # |
2020/471 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 20, 2020 |
| Est. completion date |
March 20, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
TC Erciyes University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study was conducted to determine the effect of back massage with 4% frankincense and
myrrh oil on back pain severity and comfort in patients who will undergo cardiac
electrophysiological study (EPS).
Description:
The study was conducted as a randomized controlled study. The population of the research
consists of individuals who will undergo cardiac EPS in the angio unit of a heart hospital at
a university. The sample size was determined as 20 people per group and a total of 60 people
for an effect size of 0.131 and a power of 90%. Considering that there may be sample losses,
10 more patients were taken per group, and the study was completed with 30 patients for each
group, a total of 90 people.
Randomization: Patients who met the inclusion criteria; They were assigned to one of three
groups: 1. Intervention group massaged with frankincense and myrrh oil, 2. Placebo group
massaged with jojoba oil, and 3. Control group. In hospital routine, patient appointments for
the EPS procedure are determined on a weekly basis. Since the operation day of the research
doctor who will perform the EPS procedure is Monday; Since patient rooms are not single
occupancy; In addition, groups were randomized computer according to weeks to prevent
contamination of frankincense and myrrh oil used for massage in the intervention group to the
placebo and control groups.
Data were collected with the Patient Information Form, which includes the sociodemographic
and health history of the individuals, the Visual Analogue Scale (VAS) for pain severity
assessment, and the General comfort questionary (GCQ) for comfort.
Individuals who met the inclusion criteria in the study were assigned to the 1st Intervention
group, 2nd Placebo group, and 3rd Control group in accordance with randomization, with their
informed consent. No intervention was made in the standard treatment applied in the clinic.
In a systematic review and meta-analysis study, it is reported that bed rest is recommended
for patients at wide intervals from 2 hours to 24 hours (2,4,6,12 and 24 hours) to prevent
vascular complications after cardiac catheterization.Therefore, in this study, post-procedure
back pain and comfort assessment were checked at the 4th hour, which is the clinical
ambulation routine.
Interventions applied to the intervention group: In the intervention group, 4% massage oil (3
ml jojoba fixed oil, 2% Frankincense and 2% Myrrh essential oil mixture) was applied on the
skin on the forearm. Individuals who did not develop any reaction after thirty minutes and
who met other inclusion criteria were included in the study. At the beginning of the study,
the patient information form, VAS for back pain severity, and GCQ for comfort evaluation were
applied by face-to-face interview method before the intervention. Then, in accordance with
the massage application protocol, a back massage was applied for a total of 15 minutes, using
4% massage oil. Then EPS was applied to the individuals. VAS and GCQ were applied again at
the 4th hour, which is the ambulation hour.
Interventions Applied to the placebo group: In the placebo massage group, jojoba fixed oil
was applied to the skin on the forearm. Individuals who did not develop any reaction after 30
minutes and who met other inclusion criteria were included in the study. At the beginning of
the study, a patient information form, VAS for back pain severity, and GCQ for comfort
evaluation were applied by face-to-face interview method before the intervention. Then, in
accordance with the massage application protocol, a back massage was applied for a total of
15 minutes, using jojoba fixed oil. Then EPS was applied to the individuals. VAS and GCQ were
applied again at the 4th hour, which is the ambulation hour.
Interventions Applied to the Control Group: At the beginning of the study, a patient
information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by
face-to-face interview method before the intervention. No intervention was applied to
individuals in the control group. In order to ensure standardization between the groups,
after 15 minutes of verbal communication, they were taken to the EPS process. After the
procedure, VAS and GCQ were applied again at the 4th hour, which is the ambulation hour.
Massage Application: Massage is the stimulation of soft tissues manually or mechanically. It
is applied for therapeutic purposes such as maintaining blood and lymph circulation, relaxing
muscles, reducing swelling, relieving pain, and providing sleep. The main maneuvers of
classical massage are effleurage, petrissage, friction, tapotmen and vibration. In the study,
effleurage, petrissage and friction were applied from these maneuvers. 15 to 45 minutes of
massage therapy time. It has been reported to vary between. In this study, a 15-minute back
massage was applied.
Massage application protocol: 1) The procedure is explained to the individual, his consent is
obtained, 2) Hands are washed, gloves are worn, 3) The individual is given a comfortable
sitting or lying position, 4) Curtain / screen is drawn or the room door is closed, 5) Back
area for massage 6) 3 ml of massage oil is poured into the palms and fingers, 7) A total of
15 minutes of massage is applied by applying five minutes of effleurage, 5 minutes of
petrissage, and 5 minutes of friction, 8) Gloves are removed, hands are washed and the
process is recorded.
The data were evaluated in the statistical package program of IBM SPSS Statistics Standard
Concurrent User V 26 (IBM Corp., Armonk, New York, USA). Descriptive statistics are given as
number of units (n), percent (%), mean±standard deviation (x ̅±sd), median (M), first
quartile (Q1) and third quartile (Q3). The normal distribution of the data of numerical
variables was evaluated with the Shapiro Wilk test of normality and Q-Q graphs. Homogeneity
of variances was evaluated with Levene's test. Comparisons between groups for the age
variable were made with one-way analysis of variance, and between groups for procedure time
and VAS values were made with Kruskal-Wallis analysis. The exact method of the chi-square
test was used for the intergroup comparison of categorical variables. Comparison of scale
scores between groups according to time was made with two-way analysis of variance in
repeated measurements from general linear models. Bonferroni correction was applied to
compare the main effects. A p value of <0.05 was accepted for statistical significance.
Ethics committee approval (decision no: 2020/471) from the Erciyes University Clinical
Research Ethics Committee and written permission from the unit where the study would be
conducted were obtained in order to conduct the study. In addition, those whose written
consent was obtained through the Informed Consent Form were included in the study.
