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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Güzel Nur YILDIZ, Dr. contact

554 168 04 15

g.n.yildiz@alparslan.edu.tr

Arzu KARAKAYA, Specialist contact

534 541 9556

arzu.karakaya@alparslan.edu.tr

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 groups in NCT06532201
Study groupRoleWhat they receive
Su-jok Therapy Group /EXPERIMENTAL GROUPExperimentalSu 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 GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. "VAS" will be used to determine the pain levels of cancer patients.

    Pain levels for cancer patients

    Measured: 2 months

  2. "Cancer Fatigue Scale" will be used to determine the fatigue levels of cancer patients.

    Fatigue levels for cancer patients

    Measured: 2 months

  3. "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

  4. "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.

  1. First posted1 Aug 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Resources

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)
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

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.

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