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FatigueNCT04362904

Acupressure for Fatigue in Elderly Cancer Patients

A study testing acupressure in people with Fatigue, run by TC Erciyes University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 groups in NCT04362904
Study groupRoleWhat they receive
acupressureExperimentalIn 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
controlNo interventionNo intervention was applied to the control group.

What is being measured

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

  1. 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

  2. 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.

  1. First posted27 Apr 2020
  2. Study start4 Aug 2014
  3. Primary completion10 Mar 2016
  4. Study completion10 Mar 2016

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
Parallel groups
Model description
a randomized, controlled trial in pre-test post-test design
Masking
None (open label)
Enrolment
31 participants (actual)
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

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.

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