FatigueNCT04362904
Acupressure for Fatigue in Elderly Cancer Patients
A study testing acupressure in people with Fatigue, run by TC Erciyes University.
Trial summary
The aim of this study was to investigate the effect of acupressure on the severity and level of cancer-related fatigue in elderly patients with cancer. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fatigue
- What is being tested?
- acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2014to 10 Mar 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 and over
- Who completed chemotherapy treatment for cancer at least a month ago
- Least literate
- Moderate to severe fatigue (VAS fatigue score 4 and above)
- Platelet count> 50,000
- Hemoglobin levels> 9 g / dl
- Hematocrit levels> 30%
- Patients with an estimated survival time of more than three months
Who cannot join
- Comorbidities that may cause fatigue (eg moderate and severe heart failure, hypothyroidism, diabetes, multiple sclerosis)
- Being diagnosed with a psychiatric disease
- Nerve, soft tissue and vascular disease on acupressure areas (hand and leg)
- Infection and surgery operations on acupressure areas (hand and leg)
- Patients had chemotherapy, radiotherapy or other cancer treatment planned during the study
About this study
Official title: Acupressure for Cancer Related Fatigue in Elderly Cancer Patients: A Randomized Controlled Study
The aim of this study was to investigate the effect of acupressure on the severity and level of cancer-related fatigue in elderly patients with cancer.
Read the detailed description
Participants The research was carried out in two stages: quantitative and qualitative. The quantitative phase of the study was a randomized, controlled trial in pre-test post-test design. The second phase of the study was performed as a qualitative study by using individual in-depth interview method at the end of four weeks of acupressure.
The study was conducted with the volunteers from hematology and medical oncology clinic in a university hospital, in Turkey.
At the beginning of the study, a total of 20 patients, 10 for each acupressure and control groups, were included in order to calculate the sampling size of the study. As the result of the evaluation, a total of 28 patients (14 for acupressure, 14 for control groups) with 95% confidence level and 90% strength were included in the study. It was decided that 11 patients would be added to both group to reach the total of 50 patients (25 acupressure group, 25 control group) considering withdrawals from the study. Acupressure and control groups were randomized by computerized patient selection. The study was completed with a total of 31 patients (15 acupressure, 16 control group) who met the inclusion criteria At the end of the study, 95% confidence level was found as 99% for Visual Analog Scale (VAS) and 95% for total Piper Fatigue Scale (PFS) score in acupressure and control groups.
In order to carry out the study, the permission of the Ethics Committee of the Clinical Researches (decision no: 2013/670) and written permission was received from the clinics where the study will be conducted. The study was carried out in accordance with the provisions of the Declaration of Helsinki (1995). Written informed consent was obtained from each participant.
In the qualitative phase of the study, in-depth interviews with individuals in the acupressure group were recorded with a voice recorder.
Procedure Routine treatment of the patients, added in the acupressure and control groups according to inclusion criteria, was not intervened during the study.
In order to collect the pre-test data of the patients in the acupressure group and the control group in the begining, the PFS researcher administered the patient identification form, VAS, by face-to-face interviews with the patients.
For this study, studies on literature are examined and acupressure application protocol was prepared by getting an expert opinion.
The researcher who applied acupressure participated in an acupressure course for 8 hours of training of acupuncture points and acupressure application including 4 hours of acupressure technique training.
In acupressure application, each acupuncture point was applied with acupressure device (Acu-Doctor Electro Acupuncture Device LY508). The device includes a digital display for acupuncture point location and a button for stimulating the acupuncture point after spot detection.
At the end of four weeks, VAS and PFS applied to the all patients again. In the qualitative phase of the study, the researcher took experience and opinions of the patients in the acupressure group about acupressure application during the second follow-up period. In the in-depth interview, a semi-structured Acupressure Experience Patient Opinion Form includes questions about acupressure was applied.
Preliminary Application In order to determine the operability of the Patient Introduction Form, acupressure application and its duration and the applicability of the scales 5 elderly patients with cancer were pre-treated with the acupressure. Pre-application data were excluded from the research.
Intervention Acupressure Group: For acupressure application, three acupuncture points (Liver 4 (LI4), Stomach 36 (ST36), Spleen 6 (SP6)) on both hands and legs are selected by taking expert advice and based on previous fatigue studies. The point LI4 corresponds to the midpoint between the first and second carpal bones. It is in the middle of the second metacarpal bone on the radial side. The ST36 point is located below the tibia, approximately 4 finger wide, along the outer edge of the tibia and 1.5-2 finger apart from the tibia, above the anterior tibia muscle. SP6 is located on the spleen meridian, on the inner side of the lower leg, 4 fingers above the ankle, behind the tibia. It is on the caudal edge of the tibia, three units in the proximal of the medial malleolus end region.
The acupuncture points, acupressure to be applied, were determined by the researcher at the first interview, by measuring the patients' own finger measurements and also by the acupressure device. The zones are then marked with an indelible pen. Then, the researcher in accordance with the acupressure protocol trained all the patients in the acupressure group or the individuals responsible for the care of the patients. After the participants were observed while performing acupressure correctly and after making them comfortable in all steps, the patients were given an application-training guide prepared by the researcher. The contents of the guide include information on acupuncture points and acupressure application. The participants were given a stopwatch to adjust the time with the acupressure device. In accordance with the acupressure protocol, each day for four weeks, taking into account the awakening and sleep periods of the individuals, acupressure applied for a total of 3 min to the each acupuncture points (one session 18 minutes) twice a day between 07:00 and 10:00 and 19:00 to 22:00 in the morning patients were asked to perform acupressure by their caregivers or on their own. All participants were monitored weekly by telephone.
The determined intensity, frequency and sensitivity were noted for each patients and recorded on the Patient Monitoring Chart - Patient Form. It is explained that for each acupuncture point, the procedure will start from head towards feet and the right hand side, then will continue with the point on the left side before moving to a different point. The patients were asked to record the acupressure application on the Patient Monitoring Chart-Patient Form. At the first interview, the Patient Presentation Form and the other scales were applied which took approximately 20 minutes, and the acupressure training lasted an average of 45 minutes.
The in-depth interviews conducted by the researcher at the end of the acupressure application were conducted in a suitable room in the hospital or in the patients' own homes. During the interviews, the patients' experiences were recorded with a voice recorder after obtaining the permission of the patients. Interviews took an average of 10 to 15 minutes.
Control Group: No intervention was applied to the control group.
- Conditions
- Fatigue
- Being tested
- acupressure
- Keywords
- Acupressure, Cancer, Fatigue, Elderly individuals, Nursing
- Medical subject headings
- Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | In accordance with the acupressure protocol, each day for four weeks, taking into account the awakening and sleep periods of the individuals, acupressure applied for a total of 3 min to the each acupuncture points (one session 18 minutes) twice a day between 07:00 and 10:00 and 19:00 to 22:00 in the morning patients were asked to perform acupressure by their caregivers or on their own. Receives: Other: acupressure |
| control | No intervention | No intervention was applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The scale is a 10-cm scale starts with a -0- representing "I don't feel tired", the other end is -10- "I feel very tired". 0-3 points show mild fatigue, 4-6 points moderate fatigue, 7-10 points indicate severe fatigue. The patients were asked to mark how tired they were during the last week on a scale of 0 to 10. The distance between the marked point and the lowest end of the line (0 = no fatigue) was measured in centimeters by the ruler and the numerical value was determined as the fatigue score of the patients.
Measured: four weeks
Piper Fatigue Scale
The scale evaluates the patient's subjective perception of fatigue with four sub-dimensions. These sub-dimensions are behavioral/severity sub-dimension that evaluates effects and intensity of fatigue on daily life activity (DLA), affective meaning sub-dimension that includes emotional meaning attributed to fatigue, sensory sub-dimension that reflects spiritual, physical and emotional symptoms of fatigue and cognitive/mood sub-dimension that reflects the level of effects of fatigue on cognitive functions and state of mind. The high scores obtained from the scale indicate that the perceived fatigue level is high.The validity and reliability study of the scale for the Turkish population was conducted by Can and the cronbach alpha coefficient was found to be 0.94. The cronbach's alpha coefficient in this study was 0.79 in the first follow-up and 0.94 in the second follow-up.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start4 Aug 2014
- Primary completion10 Mar 2016
- Study completion10 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- a randomized, controlled trial in pre-test post-test design
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ülkü özdemir, TC Erciyes University
- Investigators
- ülkü özdemir, Principal investigator, TC Erciyes Universitysultan taşcı, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362904
- Sponsor's protocol ID
- TDK-2014-5025
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no panning
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure for Cancer Related Fatigue in Elderly Cancer Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04362904
- Acronym / sponsor ID
- TDK-2014-5025
- Conditions
- Fatigue
- Keywords
- Acupressure, Cancer, Fatigue, Elderly individuals, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 4 Aug 2014 (actual)
- Primary completion
- 10 Mar 2016 (actual)
- Study completion
- 10 Mar 2016 (actual)
- First posted
- 27 Apr 2020 (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.
The aim of this study was to investigate the effect of acupressure on the severity and level of cancer-related fatigue in elderly patients with cancer.
Detailed description
Participants The research was carried out in two stages: quantitative and qualitative. The quantitative phase of the study was a randomized, controlled trial in pre-test post-test design. The second phase of the study was performed as a qualitative study by using individual in-depth interview method at the end of four weeks of acupressure.
The study was conducted with the volunteers from hematology and medical oncology clinic in a university hospital, in Turkey.
At the beginning of the study, a total of 20 patients, 10 for each acupressure and control groups, were included in order to calculate the sampling size of the study. As the result of the evaluation, a total of 28 patients (14 for acupressure, 14 for control groups) with 95% confidence level and 90% strength were included in the study. It was decided that 11 patients would be added to both group to reach the total of 50 patients (25 acupressure group, 25 control group) considering withdrawals from the study. Acupressure and control groups were randomized by computerized patient selection. The study was completed with a total of 31 patients (15 acupressure, 16 control group) who met the inclusion criteria At the end of the study, 95% confidence level was found as 99% for Visual Analog Scale (VAS) and 95% for total Piper Fatigue Scale (PFS) score in acupressure and control groups.
In order to carry out the study, the permission of the Ethics Committee of the Clinical Researches (decision no: 2013/670) and written permission was received from the clinics where the study will be conducted. The study was carried out in accordance with the provisions of the Declaration of Helsinki (1995). Written informed consent was obtained from each participant.
In the qualitative phase of the study, in-depth interviews with individuals in the acupressure group were recorded with a voice recorder.
Procedure Routine treatment of the patients, added in the acupressure and control groups according to inclusion criteria, was not intervened during the study.
In order to collect the pre-test data of the patients in the acupressure group and the control group in the begining, the PFS researcher administered the patient identification form, VAS, by face-to-face interviews with the patients.
For this study, studies on literature are examined and acupressure application protocol was prepared by getting an expert opinion.
The researcher who applied acupressure participated in an acupressure course for 8 hours of training of acupuncture points and acupressure application including 4 hours of acupressure technique training.
In acupressure application, each acupuncture point was applied with acupressure device (Acu-Doctor Electro Acupuncture Device LY508). The device includes a digital display for acupuncture point location and a button for stimulating the acupuncture point after spot detection.
At the end of four weeks, VAS and PFS applied to the all patients again. In the qualitative phase of the study, the researcher took experience and opinions of the patients in the acupressure group about acupressure application during the second follow-up period. In the in-depth interview, a semi-structured Acupressure Experience Patient Opinion Form includes questions about acupressure was applied.
Preliminary Application In order to determine the operability of the Patient Introduction Form, acupressure application and its duration and the applicability of the scales 5 elderly patients with cancer were pre-treated with the acupressure. Pre-application data were excluded from the research.
Intervention Acupressure Group: For acupressure application, three acupuncture points (Liver 4 (LI4), Stomach 36 (ST36), Spleen 6 (SP6)) on both hands and legs are selected by taking expert advice and based on previous fatigue studies. The point LI4 corresponds to the midpoint between the first and second carpal bones. It is in the middle of the second metacarpal bone on the radial side. The ST36 point is located below the tibia, approximately 4 finger wide, along the outer edge of the tibia and 1.5-2 finger apart from the tibia, above the anterior tibia muscle. SP6 is located on the spleen meridian, on the inner side of the lower leg, 4 fingers above the ankle, behind the tibia. It is on the caudal edge of the tibia, three units in the proximal of the medial malleolus end region.
The acupuncture points, acupressure to be applied, were determined by the researcher at the first interview, by measuring the patients' own finger measurements and also by the acupressure device. The zones are then marked with an indelible pen. Then, the researcher in accordance with the acupressure protocol trained all the patients in the acupressure group or the individuals responsible for the care of the patients. After the participants were observed while performing acupressure correctly and after making them comfortable in all steps, the patients were given an application-training guide prepared by the researcher. The contents of the guide include information on acupuncture points and acupressure application. The participants were given a stopwatch to adjust the time with the acupressure device. In accordance with the acupressure protocol, each day for four weeks, taking into account the awakening and sleep periods of the individuals, acupressure applied for a total of 3 min to the each acupuncture points (one session 18 minutes) twice a day between 07:00 and 10:00 and 19:00 to 22:00 in the morning patients were asked to perform acupressure by their caregivers or on their own. All participants were monitored weekly by telephone.
The determined intensity, frequency and sensitivity were noted for each patients and recorded on the Patient Monitoring Chart - Patient Form. It is explained that for each acupuncture point, the procedure will start from head towards feet and the right hand side, then will continue with the point on the left side before moving to a different point. The patients were asked to record the acupressure application on the Patient Monitoring Chart-Patient Form. At the first interview, the Patient Presentation Form and the other scales were applied which took approximately 20 minutes, and the acupressure training lasted an average of 45 minutes.
The in-depth interviews conducted by the researcher at the end of the acupressure application were conducted in a suitable room in the hospital or in the patients' own homes. During the interviews, the patients' experiences were recorded with a voice recorder after obtaining the permission of the patients. Interviews took an average of 10 to 15 minutes.
Control Group: No intervention was applied to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomized, controlled trial in pre-test post-test design
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Other: acupressureIn accordance with the acupressure protocol, each day for four weeks, taking into account the awakening and sleep periods of the individuals, acupressure applied for a total of 3 min to the each acupuncture points (one session 18 minutes) twice a day between 07:00 and 10:00 and 19:00 to 22:00 in the morning patients were asked to perform acupressure by their caregivers or on their own. |
| control | No intervention | –No intervention was applied to the control group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age 65 and over
- Who completed chemotherapy treatment for cancer at least a month ago
- Least literate
- Moderate to severe fatigue (VAS fatigue score 4 and above)
- Platelet count> 50,000
Key exclusion criteria (5 listed)
- Comorbidities that may cause fatigue (eg moderate and severe heart failure, hypothyroidism, diabetes, multiple sclerosis)
- Being diagnosed with a psychiatric disease
- Nerve, soft tissue and vascular disease on acupressure areas (hand and leg)
- Infection and surgery operations on acupressure areas (hand and leg)
- Patients had chemotherapy, radiotherapy or other cancer treatment planned during the study
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 |
|---|---|---|
| acupressure | Other | acupressure |
Primary outcome
Visual Analog Scale
Time frame: four weeks
The scale is a 10-cm scale starts with a -0- representing "I don't feel tired", the other end is -10- "I feel very tired". 0-3 points show mild fatigue, 4-6 points moderate fatigue, 7-10 points indicate severe fatigue. The patients were asked to mark how tired they were during the last week on a scale of 0 to 10. The distance between the marked point and the lowest end of the line (0 = no fatigue) was measured in centimeters by the ruler and the numerical value was determined as the fatigue score of the patients.
Piper Fatigue Scale
Time frame: four weeks
The scale evaluates the patient's subjective perception of fatigue with four sub-dimensions. These sub-dimensions are behavioral/severity sub-dimension that evaluates effects and intensity of fatigue on daily life activity (DLA), affective meaning sub-dimension that includes emotional meaning attributed to fatigue, sensory sub-dimension that reflects spiritual, physical and emotional symptoms of fatigue and cognitive/mood sub-dimension that reflects the level of effects of fatigue on cognitive functions and state of mind. The high scores obtained from the scale indicate that the perceived fatigue level is high.The validity and reliability study of the scale for the Turkish population was conducted by Can and the cronbach alpha coefficient was found to be 0.94. The cronbach's alpha coefficient in this study was 0.79 in the first follow-up and 0.94 in the second follow-up.
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 27 Apr 2020.
- Individual participant dataSharing planned: No. no panning
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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.
ülkü özdemir principal investigator
TC Erciyes University
sultan taşcı study director
TC Erciyes University
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Fatigue, run by TC Erciyes 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 8 inclusion and 5 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 27 Apr 2020. 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?
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?
Visual Analog Scale (time frame: four weeks). The study lists 2 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 27 Apr 2020; AzTrials last refreshed its copy on 7 Nov 2026.