Colorectal CancerNCT04810299
Effect of Aromatherapy Massage on Symptom Control
A study testing Aromatherapy and Classical foot massage in people with Colorectal Cancer, run by Sakarya University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Aromatherapy and Classical foot massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2021to 23 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Aromatherapy Massage Applied to Patients After Colorectal Surgery on Early Symptom Control
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).
Read the detailed 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.
- Conditions
- Colorectal Cancer
- Being tested
- Aromatherapy, Classical foot massage
- Keywords
- aromatherapy, foot massage, anxiety, pain, sleep quality, fatigue
- Medical subject headings
- Colorectal Neoplasms, Anxiety Disorders, Pain, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
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 massageOther
Classical foot massage; It is defined as a massage technique based on the principle of systematic relaxation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The change between the first, second and third days after surgery will be checked.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start16 Apr 2021
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Yaman, Sakarya University
- Investigators
- Dilek AYGİN, PhD, Study director, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810299
- Sponsor's protocol ID
- Özge YAMAN
- Status last verified
- Aug 2023
- First submitted
- 17 Mar 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is planned to be published after the study is completed.
Publications
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.
PubMed 39241341
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Aromatherapy Massage Applied to Patients After Colorectal Surgery on Early Symptom Control
- ClinicalTrials.gov ID
- NCT04810299
- Acronym / sponsor ID
- Özge YAMAN
- Conditions
- Colorectal Cancer
- Keywords
- aromatherapy, foot massage, anxiety, pain, sleep quality, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy Massage Group | Experimental | Other: AromatherapyAccording 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. |
| Classical Foot Massage Group | Experimental | Other: Classical foot massageBaby 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyAromatherapy; 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. | Other | Aromatherapy Massage Group |
| Classical foot massageClassical foot massage; It is defined as a massage technique based on the principle of systematic relaxation | Other | Classical Foot Massage Group |
Primary outcome
Pain levels
Time frame: The change between the first, second and third days after surgery will be checked.
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".
Anxiety levels
Time frame: The change between the first, second and third days after surgery will be checked.
Measurements will be made using the State Anxiety Scale. This scale determines how the individual feels at a particular moment and under certain conditions.
Fatigue levels
Time frame: The change between the first, second and third days after surgery will be checked.
A visual analog scale will be used.Their values range from 0-10.
Sleep quality
Time frame: The change between the first, second and third days after surgery will be checked.
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.
Nausea-vomiting
Time frame: The change between the first, second and third days after surgery will be checked.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Derived from this study: PubMed 39241341Yaman 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.
- Individual participant dataSharing planned: No. It is planned to be published after the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek AYGİN, PhD study director
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Classical foot massage in people with Colorectal Cancer, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain levels (time frame: The change between the first, second and third days after surgery will be checked.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.