Effect of Aromatherapy Massage on Pain and Anxiety After Mastectomy

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

Interventions

PROCEDURE

Aromatherapy massage with sesame- lavender oil mixed

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.

PROCEDURE

Aromatherapy massage with sesame oil

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.

PROCEDURE

Massage with parraffin oil

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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital

  collaborator OTHER

• Istanbul Medipol University Hospital

  lead OTHER

Principal Investigators

• Muzeyyen Ataseven · Istanbul Marmara Universty

• Nuray Sahin Orak · Istanbul Nisantasi University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-17

Primary Completion

2023-03-25

Completion

2023-03-25

Countries

• Turkey (Türkiye)

Study Locations