Coronary Artery DiseaseNCT05887362
The Power of Hand Reflexology in Ameliorating Anxiety, Pain, and Fatigue Among Patients Undergoing Coronary Angiography
A study testing Hand Reflexology in people with Coronary Artery Disease, run by Alexandria University at 1 site in Egypt.
Trial summary
Reflexology influences pain perception and pain-impulse transmission by releasing endorphins (12). Patients with a variety of medical illnesses can benefit from hand reflexology by lessening their physical and emotional discomfort (13, 14). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Hand Reflexology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 15 Nov 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the ages of 20 and 60 who were scheduled for non-emergency CA, Absence of any hands' sensory motor disorders, or upper limb vascular injuries.
- No abnormalities such as amputations, burns, skin lesions, and intervertebral disc herniation.
- No history of mental illnesses.
Who cannot join
- Patients with severe mental problems
Trial locations and contacts
1 site in 1 country.
About this study
Reflexology influences pain perception and pain-impulse transmission by releasing endorphins (12). Patients with a variety of medical illnesses can benefit from hand reflexology by lessening their physical and emotional discomfort (13, 14). Therefore, this study was done to investigate the power of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography
- Conditions
- Coronary Artery Disease
- Being tested
- Hand Reflexology
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand ReflexologyBehavioural
Reflexology is a well-known, safe, and noninvasive alternative medicine technique. It alludes to a treatment that is applied to particular areas of the hands and feet. The compression on the hands or feet serves as a sensor linked to particular body areas. These sensors are activated by the reflexology technique to improve blood flow, energize, relax, and maintain homeostasis.
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP | Experimental | Each patient in the study group received 8 sessions of hand reflexology after CA in a room separating them from the patients in the control group.Using pleasant odourless almond oil to lubricate the patients' hands, the researcher used Ingham's approach to hand reflexology for 10 minutes, applying pressure for 5 minutes on the right hand and then the left. Receives: Behavioral: Hand Reflexology |
| Group 2 | No intervention | The control group was selected first and received the routine care delivered by the hospital, such as assessment of vital signs, supine position, complete bed rest, and hygienic care. They didn't receive the hand reflexology intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
It is a 10 cm horizontal line with two ends; the left end typically denotes "no pain," while the right end typically denotes "worst possible pain."
Measured: 4 months
Fatigue
The Rhoten Fatigue Scale (RFS) is a subjective rating scale developed by (16) to measure a patient's fatigue level. It comprises a 10-centimeter line with extremely positive and negative statements at either end.
Measured: 4 months
Anxiety
The Beck Anxiety Inventory (BAI) was developed in 1988 by (17) to assess the severity of anxiety symptoms. The Likert scale for the 21 items that comprise the BAI ranges from 0 to 3. The overall score is between 0 and 63.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jul 2022
- Primary completion1 Nov 2022
- Study completion15 Nov 2022
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887362
- Sponsor's protocol ID
- 2022935
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali EA, Awad WHA, Khedr MA, Rabie EAEGA. Effect of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography. BMC Complement Med Ther. 2023 Nov 24;23(1):425. doi: 10.1186/s12906-023-04256-6.
PubMed 38001461
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Power of Hand Reflexology in Ameliorating Anxiety, Pain, and Fatigue Among Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT05887362
- Acronym / sponsor ID
- 2022935
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 2 Jun 2023 (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.
Reflexology influences pain perception and pain-impulse transmission by releasing endorphins (12). Patients with a variety of medical illnesses can benefit from hand reflexology by lessening their physical and emotional discomfort (13, 14). Therefore, this study was done to investigate the power of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP | Experimental | Behavioral: Hand ReflexologyEach patient in the study group received 8 sessions of hand reflexology after CA in a room separating them from the patients in the control group.Using pleasant odourless almond oil to lubricate the patients' hands, the researcher used Ingham's approach to hand reflexology for 10 minutes, applying pressure for 5 minutes on the right hand and then the left. |
| Group 2 | No intervention | –The control group was selected first and received the routine care delivered by the hospital, such as assessment of vital signs, supine position, complete bed rest, and hygienic care. They didn't receive the hand reflexology intervention. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between the ages of 20 and 60 who were scheduled for non-emergency CA, Absence of any hands' sensory motor disorders, or upper limb vascular injuries.
- No abnormalities such as amputations, burns, skin lesions, and intervertebral disc herniation.
- No history of mental illnesses.
Key exclusion criteria (1 listed)
- Patients with severe mental problems
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 |
|---|---|---|
| Hand ReflexologyReflexology is a well-known, safe, and noninvasive alternative medicine technique. It alludes to a treatment that is applied to particular areas of the hands and feet. The compression on the hands or feet serves as a sensor linked to particular body areas. These sensors are activated by the reflexology technique to improve blood flow, energize, relax, and maintain homeostasis. | Behavioural | STUDY GROUP |
Primary outcome
Pain intensity
Time frame: 4 months
It is a 10 cm horizontal line with two ends; the left end typically denotes "no pain," while the right end typically denotes "worst possible pain."
Fatigue
Time frame: 4 months
The Rhoten Fatigue Scale (RFS) is a subjective rating scale developed by (16) to measure a patient's fatigue level. It comprises a 10-centimeter line with extremely positive and negative statements at either end.
Anxiety
Time frame: 4 months
The Beck Anxiety Inventory (BAI) was developed in 1988 by (17) to assess the severity of anxiety symptoms. The Likert scale for the 21 items that comprise the BAI ranges from 0 to 3. The overall score is between 0 and 63.
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 2 Jun 2023.
- Derived from this study: PubMed 38001461Ali EA, Awad WHA, Khedr MA, Rabie EAEGA. Effect of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography. BMC Complement Med Ther. 2023 Nov 24;23(1):425. doi: 10.1186/s12906-023-04256-6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Reflexology in people with Coronary Artery Disease, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 1 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 2 Jun 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 Egypt. 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 intensity (time frame: 4 months). The study lists 3 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 NCT05887362, 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 2 Jun 2023.