Effect of Aromatherapy Massage on Pain and Anxiety After Mastectomy

NCT05658367 | Completed

• 1 other identifier: mataseven
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

This study is an interventional type three-group randomized controlled non-drug clinical trial aimed at targeting the acute pain content and anxiety level of aromatherapy arm treatment with a sesame oil and sesame lavender oil mixture performed with Simple Mastectomy (BM) / Modified Radical Mastectomy (MRM). It constitutes a total of 66 patients with the power to represent the universe. However, considering the losses that may occur during the study process, it was decided that it would be appropriate to include 90 patients, 36% more than the sample. Individuals receiving arm massage with sesame oil (Group I), individuals performing arm massage with sesame-lavender oil mixture (Group II), and individuals performing arm massage with paraffin oil (Group III) constitute the research groups. After obtaining the informed written consent of the participants who agreed to participate in the study, the randomization list created from the computer-based random numbers table will be used with the block randomization method to assign an equal number of people to all three groups. In the preoperative period, patients will be given an allergic sensitivity (patch) test of the oils to be used in the study to Groups 1 and 2, massage training will be given to all groups with the show-and-have method in the pre-operative period, a massage application brochure and video will be given, and information will be given on how to fill out the follow-up forms. H1: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with sesame oil reduces the severity of acute arm pain compared to massage with paraffin oil.H2: After simple mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces the severity of acute arm pain compared to massage with paraffin oil.H3: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with sesame oil reduces anxiety levels compared to massage with paraffin oil.H4: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces anxiety levels compared to massage with paraffin oil.H5: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces the severity of acute arm pain compared to massage with sesame oil.H6: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces anxiety levels compared to massage with sesame oil.

Conditions

Acute Pain; Anxiety; Mastectomy; Massage Therapy; Aromatherapy

Outcome Measures

Primary Outcomes (2)

• Change in NUMERICAL PAIN SCALE (NUMERİCAL RATING SCALE- NRS)

  It is based on the expression of pain intensity in numbers. In numerical scales, 0 points define the absence of pain, while the value of the number increases as the severity of pain increases, and 10 points indicate unbearable pain

  In the postoperative period, the patient's pain is recorded at 08:00 and 08:30, 20:00 and 20:30 with analgesic application, and at 11:00, 11:15 and 23:00 and 23:15 with massage application.

• STATUS ANXIETY SCALE

  It is a 20-item scale used to measure the instantaneous anxiety level of individuals.

  Instant anxiety data of the patient are recorded in the postoperative period, at the 15th minute after the massage.

Secondary Outcomes (5)

• VITAL FINDINGS REGISTRATION FORM

  In the postoperative period, the patient's body temperature is recorded 0 minutes before the analgesic, 30 minutes after the analgesic, 0 minutes before the massage and 15 minutes after the massage.

• ANALGESIC FOLLOW-UP FORM

  Data are taken from the patient's file during the hospitalization for 2 days.

• VITAL FINDINGS REGISTRATION FORM

  In the postoperative period, the patient's pulse is recorded 0 minutes before the analgesic, 30 minutes after the analgesic, 0 minutes before the massage and 15 minutes after the massage.

• VITAL FINDINGS REGISTRATION FORM

  In the postoperative period, the patient's respiratory is recorded 0 minutes before the analgesic, 30 minutes after the analgesic, 0 minutes before the massage and 15 minutes after the massage.

• VITAL FINDINGS REGISTRATION FORM

  In the postoperative period, the patient's blood pressure is recorded 0 minutes before the analgesic, 30 minutes after the analgesic, 0 minutes before the massage and 15 minutes after the massage.

Other Outcomes (6)

• NUMERICAL PAIN SCALE (NUMERİCAL RATING SCALE- NRS)

  The patient's pain is recorded in the preoperative period.

• STATUS ANXIETY SCALE

  Instant anxiety data of the patient are recorded in the preoperative period.

• VITAL FINDINGS REGISTRATION FORM

  The body temperature of the patient are recorded in the preoperative period.

Study Arms (3)

Group 1

ACTIVE COMPARATOR

\- Group I: The group applied arm massage with sesame oil

Procedure: Aromatherapy massage with sesame oil

Group 2

EXPERIMENTAL

\- Group II: The group applied arm massage with a mixture of sesame-lavender oil

Procedure: Aromatherapy massage with sesame- lavender oil mixed

Group 3

PLACEBO COMPARATOR

\- Group III (Control): The group applied arm massage with paraffin oil

Procedure: Massage with parraffin oil

Interventions

Aromatherapy massage with sesame- lavender oil mixed PROCEDURE

After the surgery, 3 hours after the painkiller application, the patients will massage their arms with sesame- lavender oil mixed for 15 minutes with classical massage manipulations.

Also known as: Group 1

Group 2

Aromatherapy massage with sesame oil PROCEDURE

After the surgery, 3 hours after the painkiller application, the patients will massage their arms with sesame oil for 15 minutes with classical massage manipulations.

Also known as: Group 2

Group 1

Massage with parraffin oil PROCEDURE

After the surgery, 3 hours after the painkiller application, the patients will massage their arms with paraffin oil for 15 minutes with classical massage manipulations.

Also known as: Group 3 (Placebo- Control)

Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Breast cancer is the most frequently diagnosed type of cancer among women worldwide, and breast cancer ranks first among the most common cancers in women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over,
• literate,
• Agreeing to participate in the study,
• Person, place, and time orientation,
• Visual (except for those with better vision using a visual aid), auditory communication difficulties (except for those with better hearing ability using a hearing aid) that will prevent them from understanding the information given and expressing the pain situation correctly,
• No speech impediment/communication problem,
• Simple mastectomy (BM) and modified radical mastectomy (MRM) were performed,
• Not using any TAT method,
• Able to use technology (smartphone, computer, etc.),
• Individuals with technology devices (smartphone, tablet, computer, etc.)

You may not qualify if:

• Not speaking Turkish and illiterate in Turkish,
• Those who are allergic to the oils to be used in the massage during the application,
• Involved in a different study conducted in the clinic,
• Breast prosthesis placed during surgery,
• Having physical and cognitive problems at a level that cannot apply massage,
• Individuals diagnosed with mood disorders (using any medication for depression, panic attacks, dysthymia, or bipolar disorder)
• Transferred to the intensive care unit in the postoperative period,
• Severe bleeding, hematoma, seroma, nerve injury, or lymphedema developing in the postoperative period,
• Developing an allergy to the oils to be used in the massage during the application,
• Those who want to leave work voluntarily,
• Individuals who do not comply with the working process and conditions will be excluded from the study.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator

Study Sites (2)

Sisli Etfal Training and Research Hospital

Istanbul, Eyalet/Yerleşke, Turkey (Türkiye)

Location

Sisli Etfal Training and Research Hospital

Istanbul, 34396, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders

Interventions

Sesame Oil; Massage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Muzeyyen Ataseven

  Istanbul Marmara Universty

  PRINCIPAL INVESTIGATOR

• Nuray Sahin Orak

  Istanbul Nisantasi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Although there is information in the literature that it is not possible to blind the participants due to the characteristic smell of aromatherapy oils, patients are shown blind in aromatherapy massage because the oils are formulated and the oil content is not known by the patients (Nasiri and Farsi, 2017; Rasooli et al., 2016). Due to the feasibility and nature of the study, the principal investigator cannot be blinded during grouping, while blinding will be provided for the patients and the analyst.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: The research was carried out to determine the effect of aromatherapy arm massage with sesame oil, sesame-lavender oil mixture, and paraffin oil on acute pain severity and anxiety level in women who underwent Interventional Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM). The study design arm is three groups and a randomized controlled, double-blind, drug-free clinical trial.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 20, 2022
• Study Start: May 17, 2022
• Primary Completion: March 25, 2023
• Study Completion: March 25, 2023
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)