Effect of Aromatherapy Massage on Symptom Control

NCT04810299 | Completed

• 1 other identifier: Özge YAMAN
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Although the incidence of colorectal cancers is high, it is often possible to treat it when diagnosed at an early stage. Although the treatment options vary according to many factors such as the type and stage of the cancer, possible side effects, the preference of the patient, and the general health status, surgery stands out as the most commonly used treatment method. However, in addition to the methods and drugs used in the diagnosis and treatment process, temporary or permanent stomas that are opened to ensure discharge cause biopsychosocial effects on the life of the individual and lead to deterioration of the quality of life. In this context, knowing and resolving the problems experienced by patients in the pre-operative and post-surgical period, which is the most commonly used treatment method, will also increase the quality of life of patients. In the literature, it was stated that patients experienced high levels of anxiety before colorectal surgery and this situation caused emotional and cognitive reactions; in the postoperative period, it is seen that they experience many problems such as anxiety, restlessness, fatigue, gastrointestinal dysfunction, pain, loss of control (inability to control gas and stool output), decreased appetite, insomnia, nausea-vomiting, abdominal distension, constipation. However, modern treatment methods, drug and non-drug treatments used to control these symptoms are not effective in some cases. At this stage, complementary and alternative medicine applications come into play, one or more of these methods are used to alleviate symptoms and increase well-being during traditional treatments. In this study, it was planned to evaluate the effect of aromatherapy massage after colorectal surgery on postoperative symptom control (pain, anxiety, fatigue, sleep quality, nausea-vomiting, flatulence).

Conditions

Colorectal Cancer

Keywords

aromatherapy; foot massage; anxiety; pain; sleep quality; fatigue

Outcome Measures

Primary Outcomes (5)

• Pain levels

  A visual analog scale will be used, with a score expressing painlessness on one side and unbearable pain on the other. Their values range from 0-10. Absence of pain is defined as "0 points" and unbearable pain is defined as "10 points".

  The change between the first, second and third days after surgery will be checked.

• Anxiety levels

  Measurements will be made using the State Anxiety Scale. This scale determines how the individual feels at a particular moment and under certain conditions.

  The change between the first, second and third days after surgery will be checked.

• Fatigue levels

  A visual analog scale will be used.Their values range from 0-10.

  The change between the first, second and third days after surgery will be checked.

• Sleep quality

  The Richard-Campbell Sleep Quality Scale will be used. This scale evaluates the depth of night sleep, the duration of falling asleep, the frequency of awakening, the duration of being awake when awakened, the quality of sleep, and the noise level in the environment.

  The change between the first, second and third days after surgery will be checked.

• Nausea-vomiting

  There are four options in the Post-operative Nausea Vomiting Impact Scale, which consists of two questions, with 0, 1, 2, 3 points for each question. The first question is whether there is vomiting or retching, the frequency is questioned, the second question is whether there is nausea (feeling of discomfort in the stomach and vomiting), if there is a feeling of nausea, you can get out of bed, move comfortably in bed, walk normally or your daily life activities such as eating and drinking. whether it affects or not is questioned.

  The change between the first, second and third days after surgery will be checked.

Study Arms (3)

Aromatherapy Massage Group

EXPERIMENTAL

According to this Tisserand Institute guide chart, for a 2% dilution process, dilution will be provided with a total of 12 drops by adding 4:4:4 drops of lavender, Roman chamomile and ginger essential oils in 20 ml of sweet almond oil. Expert opinion was obtained from a phytotherapy and aromatherapy specialist physician that the oils and dilution rates used were appropriate. Foot massage will be applied on the 1st, 2nd and 3rd postoperative days. State Anxiety Scale, Visual Analogue Scale (VAS-F), Visual Analogue Scale (VAS-P), Post-operative Nausea-Vomiting Impact Scale will be applied before and after the application.Richard-Campbell Sleep Quality Scale will be applied before application Foot massage will be applied for 20 minutes.

Other: Aromatherapy

Classical Foot Massage Group

EXPERIMENTAL

Baby oil will be applied as massage oil to patients who are assigned to the classical foot massage group before the surgery. Foot massage will be applied for 20 minutes on the 1st,2nd and 3rd days. State Anxiety Scale, Visual Analogue Scale (VAS-F), Visual Analogue Scale (VAS-P), Post-operative Nausea-Vomiting Impact Scale will be applied before and after the application.Richard-Campbell Sleep Quality Scale will be applied before application

Other: Classical foot massage

Control Group

NO INTERVENTION

Except for routine care practices, no attempt will be made to the patients assigned to the pre-operative control group. State Anxiety Scale, Richard-Campbell Sleep Quality Scale, Visual Analogue Scale (VAS-F), Visual Analogue Scale (VAS-P), Post-operative Nausea-Vomiting Impact Scale will be applied on postoperative 1st, 2nd and 3rd days. The same scales will be re-evaluated 60 minutes after the first measurement. Richard-Campbell Sleep Quality Scale will be applied once

Interventions

Aromatherapy OTHER

Aromatherapy; It is one of the complementary therapy methods defined as the therapeutic use of essential oils obtained from parts of plants such as root, seed, leaf, flower, shell with appropriate methods.

Aromatherapy Massage Group

Classical foot massage OTHER

Classical foot massage; It is defined as a massage technique based on the principle of systematic relaxation

Classical Foot Massage Group

Eligibility Criteria

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

You may qualify if:

• Are over the age of 18
• Can understand and speak Turkish
• No mental or neurological disorders that may affect communication skills
• Not allergic to aromatic oils for aromatherapy massage group
• Patients undergoing curative surgery
• Not using antidepressant medication
• With an ASA score of 1-2-3
• Undergoing elective surgery
• Follow-up in the service after surgery
• No secondary cancer and recurrence surgery
• No contraindications for foot massage
• No major complications (bleeding, obstruction, anastomotic leak etc.) during the postoperative period
• Individuals who agree to participate in the study will be included.

You may not qualify if:

• Under the age of 18
• Cannot understand and speak Turkish
• Having a mental or neurological condition that affects communication skills
• For aromatherapy massage group, allergic to aromatic oils
• Having had aromatherapy practice before
• Refusing to participate in research
• Stage IV patients
• Using antidepressant medication
• Emergency surgery applied
• ASA score of 4-5
• Permanent stoma opening
• Follow-up in intensive care after surgery
• Secondary cancer or surgery after relapse
• Major complications during the postoperative period
• Contraindicated for foot massage application (paraplegia, acute gout, foot ulcer, thrombosis, peripheral vascular disease, diffuse edema or lymphedema, acute foot injury or fracture)

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Location

Related Publications (1)

• Yaman O, Aygin D, Altintoprak F, Guclu E. The effects of aromatherapy massage given to patients after colorectal cancer surgery on symptom management: A randomized controlled study. Complement Ther Clin Pract. 2024 Nov;57:101900. doi: 10.1016/j.ctcp.2024.101900. Epub 2024 Sep 2.

  PMID: 39241341 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Anxiety Disorders; Pain; Sleep Initiation and Maintenance Disorders; Fatigue

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dilek AYGİN, PhD

  Sakarya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: April 16, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)