The Effect of Back Massage Before the Cardiac Electrophysiological Procedure

NCT05113992 | Completed

• 1 other identifier: 2020/471
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Massage

Keywords

Electrophysiological study; Comfort; Back Pain; Massage; Frankincense and Myrrh

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  It was used to evaluate the severity of back pain. The patient marks his or her own pain on a 10 cm ruler with painlessness (0) on one end and the most severe pain (10) on the other. The distance between the onset of "no pain" and this point marked by the patient is measured and recorded in centimeters. A high score indicates a high pain intensity.

  four hours

• General Comfort Questionary

  It was developed by Kolcaba in 1992. It was used to evaluate comfort. The scale is a four-point Likert type, positive and negative contains a total of 48 items. There are four sub-dimensions that physical, psychospiritual, environmental and sociocultural. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. The average value is determined by dividing the total score obtained by the number of scale items and the result is indicated in the 1-4 distribution. Low comfort is expressed by one and high comfort by four.

  four hours

Study Arms (3)

Intervention group massaged with frankincense and myrrh oil

EXPERIMENTAL

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.

Other: aromatherapy massage

. Placebo group massaged with jojoba oil,

SHAM COMPARATOR

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.

Other: classic massage

Control group

NO INTERVENTION

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.

Interventions

aromatherapy massage OTHER

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

Intervention group massaged with frankincense and myrrh oil

classic massage OTHER

In the placebo massage group, jojoba fixed oil was applied to the skin on the forearm.

. Placebo group massaged with jojoba oil,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are over 18 years old;
• agreeing to participate in the study;
• EPS planned from the femoral region;
• no communication problems (hearing, vision, speech, perception problems);
• According to VAS, there is no pain in any part of the body before the procedure;
• individuals who did not develop any reaction 30 minutes after applying the oils to be used on the skin on the forearm were included in the study.

You may not qualify if:

• Those who had an allergic skin reaction,
• skin disease in the back region,
• a history of fractures or surgical operations in the waist and back region in the last year,
• those who had neurological disorders (hemiparesis, etc.),
• those who received massage therapy in the last three months, those who were diagnosed with cancer,
• those who suffered from acute myocardial infarction were excluded.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Ülkü Özdemir

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• ülkü özdemir

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor doctor

Model Details: 1\. Intervention group 2. Placebo group 3. Control group. a randomized controlled study

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 9, 2021
• Study Start: October 20, 2020
• Primary Completion: March 20, 2021
• Study Completion: March 20, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)