Effect of Aromatherapy Massage on Symptom Control

Colorectal Cancer Clinical Trial

Official title:

Evaluation of the Effect of Aromatherapy Massage Applied to Patients After Colorectal Surgery on Early Symptom Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810299
• Other study ID #: Özge YAMAN
• Status: Completed
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: March 23, 2023

Study information

• Verified date: August 2023
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The population of the study will consist of patients who underwent colorectal cancer surgery between June 2021 and June 2022, and the sample of patients who meet the criteria for inclusion in the study.The sample was planned to be 90 people, 30 patients for each of the aromatherapy massage, classical foot massage and control groups. However, power analysis was also performed to calculate the minimum sample size to be reached. In the study, it was aimed to evaluate the differences in mean scale between three groups, including one control and two experiments. When it is not known how many units of difference between groups are important, the effect width value is taken as 0.35 as the method used. The effect width value gives results with a very high constraint of 0.10, medium level of 0.25 and a maximum acceptance constraint of 0.40. The total number of patients was 84, including 28 patients in the groups, with an error margin of 5% and a width of effect value of 0.35 at 81.19% power level.Block Randomization technique will be used in the sample selection of the research. In order to blind the randomization, it was made by a statistician who was not related to the research and the group rankings were put in 9 envelopes and numbered by another person who was not related to the research. For data collection Patient Information Form , Visual Analog Scale (VAS-Pain), Visual Analog Scale (VAS-Fatigue), Richard-Campbell Sleep Quality Scale, State Anxiety Scale, Post-operative Nausea-Vomiting Effect Scale will be used.The first interview with the patients will be held in the preoperative period and information will be given about the research. For patients who agree to participate in the study, a Patient Information Form will be filled out and a group assignment will be made using the block randomization method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

• Having a pacemaker, uncontrolled hypertension, uncontrolled thyroid problems, epilepsy, bladder or kidney stones

• Patients with signs of active infection and fever will not be included in the study.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Aromatherapy
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.
• Classical foot massage
Classical foot massage; It is defined as a massage technique based on the principle of systematic relaxation

Locations

Country	Name	City	State
Turkey	Sakarya University	Sakarya	Serdivan

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.