CancerNCT06532201
Effects of Su Jok Therapy on Pain, Fatigue, Nausea-Vomiting and Spiritual Well-Being
A study testing Su jok seed therapy in people with Cancer and Chemotherapy, run by Muş Alparslan University.
Trial summary
This study aims to examine the effects of sujok therapy on pain, fatigue, nausea-vomiting and spiritual well-being levels in patients receiving chemotherapy. The following questions are being answered; Does sujok therapy affect pain levels in cancer patients? Does sujok therapy affect fatigue levels in cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy
- What is being tested?
- Su jok seed therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Jan 2025
- 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
- Being over 18 years old
- Being diagnosed with cancer
- Being receiving chemotherapy
- No communication problems
Who cannot join
- Deterioration or death during the research process
- Requesting to withdraw from the research
- Incomplete filling of forms
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Su Jok Therapy on Pain, Fatigue, Nausea-Vomiting and Spiritual Well-Being Levels in Patients Receiving Chemotherapy
This study aims to examine the effects of sujok therapy on pain, fatigue, nausea-vomiting and spiritual well-being levels in patients receiving chemotherapy. The following questions are being answered;
- Does sujok therapy affect pain levels in cancer patients?
- Does sujok therapy affect fatigue levels in cancer patients?
- Does sujok therapy affect nausea-vomiting levels in cancer patients?
- Does sujok therapy affect spiritual well-being levels in cancer patients?
Read the detailed description
Location of the study:
Research data will be collected in the oncology unit of Muş State Hospital.
Research universe, sample, research group:
The research universe will consist of patients who apply to the oncology service in the hospital where the study is conducted and receive treatment. It was determined that the required sample size for the study to exceed 80% with a 95% confidence interval, 0.05 significance level and medium effect size was 68 people, with 34 people in each group.
Data collection tools:
"Descriptive Characteristics Form" and "Visual Analog Scale-VAS", "Cancer Fatigue Scale", "Rhodes Nausea-Vomiting and Retching Index" and "Spiritual Well-Being Scale" will be used as data collection tools.
Descriptive Characteristics Form This form includes questions such as patients' age, gender, socioeconomic level, and educational status.
Visual Analog Scale-VAS: The severity of the symptom experienced by the patient is measured by marking a numbered point on this line. VAS markings are repeated before and during the procedure, regardless of the previous marking location. In this study, a 0-10 point scale will be used to evaluate the pain levels of individuals with VAS.
Cancer Fatigue Scale (KPSS): Its validity and reliability in Turkey was conducted by Şahin et al. in 2018. The scale, consisting of a total of 15 items and three sub-dimensions, has a 5-point Likert structure. The highest score that can be obtained from the scale is 60 points. It is stated that the higher the score, the higher the fatigue level. The internal consistency coefficient of the scale is 0.74.
Rhodes nausea-vomiting and retching index (NBSI): Its validity and reliability in Turkish was conducted by Tan and Genç. The scale, which has a five-point Likert structure (0= least distress level, 4= most distress), has eight items that measure the number and severity of nausea-vomiting-retching in the last 24 hours. The highest score that can be obtained from the scale is 32, and it is stated that the distress level increases as the score increases. The internal consistency coefficient of the scale is 0.95. Spiritual Well-Being Scale: Its Turkish adaptation was made by Aktürk et al. (2017). The scale was created to determine the spiritual well-being of cancer patients or individuals with other chronic diseases. The scale is a five-point Likert type and consists of 12 items. The items of the scale have a numbering system between 0 and 4 (0-Not at all, 4-A lot). The total score of the scale is 0-48 points. A higher scale score indicates better spiritual well-being. The total Cronbach alpha value of the scale is 0.87.
RANDOMIZATION Patients who apply to the oncology unit for chemotherapy will be numbered according to the order of application. Patients will be divided into experimental and control groups using the "RANDOMIZER" program.
Control group: No intervention will be made to this group. When participating in the study, participants will be asked to fill out the "Visual Analog Scale-VAS", "Cancer Fatigue Scale", "Rhodes Nausea-Vomiting and Retching Index" and "Spiritual Well-Being Scale" after one and two months.
Experimental group: Su jok therapy will be applied to this group using black pepper seeds. A total of 8 sessions (twice a week for 4 weeks) of therapy will be applied. Black pepper seeds will be placed on a certain point of the patient's hand and taped. After two hours, they will be asked to remove and throw away. When participating in the study, after one and two months, participants will be asked to fill out the "Visual Analog Scale-VAS", "Cancer Fatigue Scale", "Rhodes Nausea-Vomiting and Retching Index" and "Spiritual Well-Being Scale".
In the last stage, the data obtained will be compared within and between groups.
- Conditions
- Cancer, Chemotherapy
- Being tested
- Su jok seed therapy
- Keywords
- su-jok, cancer patients, Pain, fatigue, nausea-vomiting, spiritual well-being
- Medical subject headings
- Neoplasms, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Su jok seed therapyOther
Su Jok will be applied to the reflection points on the hand based on the painful area of the individual. The painful areas will be determined with the applicator and black pepper seeds will be placed on these areas. Circular massage will be applied to the areas where the seeds are located for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Su-jok Therapy Group /EXPERIMENTAL GROUP | Experimental | Su Jok will be applied to the reflection points on the hand based on the painful area of the individual. The painful areas will be determined with the applicator and black pepper seeds will be placed on these areas. Circular massage will be applied to the areas where the seeds are located for 30 minutes. Receives: Other: Su jok seed therapy |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
"VAS" will be used to determine the pain levels of cancer patients.
Pain levels for cancer patients
Measured: 2 months
"Cancer Fatigue Scale" will be used to determine the fatigue levels of cancer patients.
Fatigue levels for cancer patients
Measured: 2 months
"Rhodes nausea-vomiting and retching index" will be used to determine the nausea-vomiting levels of cancer patients.
Nausea-vomiting levels for cancer patients
Measured: 2 months
"Spiritual Well-Being Scale" will be used to determine the spiritual well-being levels of cancer patients.
Spiritual well being levels for cancer patients
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzel Nur Yıldız, Dr, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532201
- Sponsor's protocol ID
- Mus Alparslan U
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Su Jok Therapy on Pain, Fatigue, Nausea-Vomiting and Spiritual Well-Being Levels in Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT06532201
- Acronym / sponsor ID
- Mus Alparslan U
- Conditions
- Cancer, Chemotherapy
- Keywords
- su-jok, cancer patients, Pain, fatigue, nausea-vomiting, spiritual well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 1 Aug 2024 (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.
This study aims to examine the effects of sujok therapy on pain, fatigue, nausea-vomiting and spiritual well-being levels in patients receiving chemotherapy. The following questions are being answered;
- Does sujok therapy affect pain levels in cancer patients?
- Does sujok therapy affect fatigue levels in cancer patients?
- Does sujok therapy affect nausea-vomiting levels in cancer patients?
- Does sujok therapy affect spiritual well-being levels in cancer patients?
Detailed description
Location of the study:
Research data will be collected in the oncology unit of Muş State Hospital.
Research universe, sample, research group:
The research universe will consist of patients who apply to the oncology service in the hospital where the study is conducted and receive treatment. It was determined that the required sample size for the study to exceed 80% with a 95% confidence interval, 0.05 significance level and medium effect size was 68 people, with 34 people in each group.
Data collection tools:
"Descriptive Characteristics Form" and "Visual Analog Scale-VAS", "Cancer Fatigue Scale", "Rhodes Nausea-Vomiting and Retching Index" and "Spiritual Well-Being Scale" will be used as data collection tools.
Descriptive Characteristics Form This form includes questions such as patients' age, gender, socioeconomic level, and educational status.
Visual Analog Scale-VAS: The severity of the symptom experienced by the patient is measured by marking a numbered point on this line. VAS markings are repeated before and during the procedure, regardless of the previous marking location. In this study, a 0-10 point scale will be used to evaluate the pain levels of individuals with VAS.
Cancer Fatigue Scale (KPSS): Its validity and reliability in Turkey was conducted by Şahin et al. in 2018. The scale, consisting of a total of 15 items and three sub-dimensions, has a 5-point Likert structure. The highest score that can be obtained from the scale is 60 points. It is stated that the higher the score, the higher the fatigue level. The internal consistency coefficient of the scale is 0.74.
Rhodes nausea-vomiting and retching index (NBSI): Its validity and reliability in Turkish was conducted by Tan and Genç. The scale, which has a five-point Likert structure (0= least distress level, 4= most distress), has eight items that measure the number and severity of nausea-vomiting-retching in the last 24 hours. The highest score that can be obtained from the scale is 32, and it is stated that the distress level increases as the score increases. The internal consistency coefficient of the scale is 0.95. Spiritual Well-Being Scale: Its Turkish adaptation was made by Aktürk et al. (2017). The scale was created to determine the spiritual well-being of cancer patients or individuals with other chronic diseases. The scale is a five-point Likert type and consists of 12 items. The items of the scale have a numbering system between 0 and 4 (0-Not at all, 4-A lot). The total score of the scale is 0-48 points. A higher scale score indicates better spiritual well-being. The total Cronbach alpha value of the scale is 0.87.
RANDOMIZATION Patients who apply to the oncology unit for chemotherapy will be numbered according to the order of application. Patients will be divided into experimental and control groups using the "RANDOMIZER" program.
Control group: No intervention will be made to this group. When participating in the study, participants will be asked to fill out the "Visual Analog Scale-VAS", "Cancer Fatigue Scale", "Rhodes Nausea-Vomiting and Retching Index" and "Spiritual Well-Being Scale" after one and two months.
Experimental group: Su jok therapy will be applied to this group using black pepper seeds. A total of 8 sessions (twice a week for 4 weeks) of therapy will be applied. Black pepper seeds will be placed on a certain point of the patient's hand and taped. After two hours, they will be asked to remove and throw away. When participating in the study, after one and two months, participants will be asked to fill out the "Visual Analog Scale-VAS", "Cancer Fatigue Scale", "Rhodes Nausea-Vomiting and Retching Index" and "Spiritual Well-Being Scale".
In the last stage, the data obtained will be compared within and between groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Su-jok Therapy Group /EXPERIMENTAL GROUP | Experimental | Other: Su jok seed therapySu Jok will be applied to the reflection points on the hand based on the painful area of the individual. The painful areas will be determined with the applicator and black pepper seeds will be placed on these areas. Circular massage will be applied to the areas where the seeds are located for 30 minutes. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years old
- Being diagnosed with cancer
- Being receiving chemotherapy
- No communication problems
Key exclusion criteria (3 listed)
- Deterioration or death during the research process
- Requesting to withdraw from the research
- Incomplete filling of forms
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 |
|---|---|---|
| Su jok seed therapySu Jok will be applied to the reflection points on the hand based on the painful area of the individual. The painful areas will be determined with the applicator and black pepper seeds will be placed on these areas. Circular massage will be applied to the areas where the seeds are located for 30 minutes. | Other | Su-jok Therapy Group /EXPERIMENTAL GROUP |
Primary outcome
"VAS" will be used to determine the pain levels of cancer patients.
Time frame: 2 months
Pain levels for cancer patients
"Cancer Fatigue Scale" will be used to determine the fatigue levels of cancer patients.
Time frame: 2 months
Fatigue levels for cancer patients
"Rhodes nausea-vomiting and retching index" will be used to determine the nausea-vomiting levels of cancer patients.
Time frame: 2 months
Nausea-vomiting levels for cancer patients
"Spiritual Well-Being Scale" will be used to determine the spiritual well-being levels of cancer patients.
Time frame: 2 months
Spiritual well being levels for cancer patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Su jok seed therapy in people with Cancer and Chemotherapy, run by Muş Alparslan University.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Güzel Nur YILDIZ, Dr. (554 168 04 15, g.n.yildiz@alparslan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"VAS" will be used to determine the pain levels of cancer patients. (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.