Cancer PainNCT07916402
Home-Based Foot Reflexology for Pain in Patients With Advanced Cancer
A study testing Foot Reflexology in people with Cancer Pain and Advanced Cancer, run by Rawan AlAssaf at 1 site in Jordan.
Trial summary
This study examined changes in pain during a home-based foot reflexology program for adults with advanced cancer in Jordan. Foot reflexology involves applying pressure to selected areas of the feet. The main questions were: 1. How did pain scores change immediately after each foot reflexology session? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Advanced Cancer
- What is being tested?
- Foot Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJordan
- Study dates
- 7 Feb 2025to 11 Apr 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
- Age 18 years or older.
- Diagnosis of advanced cancer, characterized using the tumor-node-metastasis (TNM) classification.
- Moderate-to-severe cancer-related pain, defined as a Numerical Pain Rating Scale (NPRS) score of 4 or higher, reported to the pain clinic.
Who cannot join
- Gout.
- Leg ulcers.
- Peripheral vascular disease.
- Deep vein thrombosis.
- Infections, wounds, or bruises that could interfere with foot reflexology.
- Lymphedema that could interfere with foot reflexology.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Military Oncology Center, Queen Alia Military Hospital
Amman, Amman Governorate, 11623
About this study
Official title: Changes in Pain Intensity During Home-Based Foot Reflexology in Patients With Advanced Cancer: A Prospective Study
This study examined changes in pain during a home-based foot reflexology program for adults with advanced cancer in Jordan. Foot reflexology involves applying pressure to selected areas of the feet.
The main questions were:
Read more
- How did pain scores change immediately after each foot reflexology session?
- How did pain scores change over the eight-week program?
Participants received up to 15 at-home sessions over eight weeks, usually twice a week. Each session included 30 minutes of foot reflexology delivered by a trained, certified practitioner. Participants rated their pain from 0 (no pain) to 10 (worst possible pain) immediately before each session and within five minutes after.
All participants continued their usual cancer treatment and pain care. Everyone received foot reflexology; there was no separate comparison group. Researchers compared each participant's pain scores before and after sessions and across the program.
Read the detailed description
This prospective, single-group, nonrandomized interventional study included repeated pain assessments. Adults with advanced cancer and moderate-to-severe cancer-related pain were recruited through the outpatient pain and oncology clinics of a military oncology center in Amman, Jordan. Researchers delivered the intervention in participants' homes. The study had no concurrent control group, random allocation, or masking.
The study examined two patterns of pain change: immediate within-session changes and longitudinal changes during the intervention period. We assessed immediate changes by comparing pain scores recorded before and after each session. We assessed longitudinal changes by examining pre-session pain scores across the program.
The intervention followed a standardized Sorensensistem foot reflexology protocol. A certified reflexology practitioner delivered up to 15 sessions over eight weeks, generally twice weekly. Each home visit lasted approximately 40 minutes, including preparation and pre-session assessment, 30 minutes of manual foot reflexology, and post-session assessment and rest. Participants were instructed to report discomfort, which would prompt termination of the session.
Pain intensity was measured using the 11-point Numerical Pain Rating Scale, ranging from 0 (no pain) to 10 (worst possible pain). Assessments were completed immediately before each session and within five minutes after. We also collected baseline demographic and clinical information.
Participants continued their prescribed oncology treatment and supportive care. We documented changes in prescribed analgesics and cancer treatments during the intervention period. We provided foot reflexology as an adjunct to usual care, not as a replacement for prescribed treatment.
Pain assessments were limited to the eight-week intervention period. We conducted no follow-up assessments after the program ended. Because the study did not include a control group, we cannot determine whether foot reflexology itself caused the observed changes in pain.
- Conditions
- Cancer Pain, Advanced Cancer
- Being tested
- Foot Reflexology
- Keywords
- Foot Reflexology, Pain Management, Home-Based Intervention, Nonpharmacological Intervention, Supportive Cancer Care, Numerical Pain Rating Scale
- Medical subject headings
- Cancer Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot ReflexologyOther
A certified practitioner delivered a standardized manual foot reflexology intervention following the Sorensensistem protocol in participants' homes. Treatment involved applying pressure to selected areas of the feet in a predefined sequence. Each treatment session lasted 30 minutes, and participants received up to 15 sessions over eight weeks, generally twice weekly. The intervention was provided alongside usual medical and oncology care.
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Foot Reflexology | Experimental | Participants received up to 15 home-based foot reflexology sessions over eight weeks, generally twice weekly. Each session included 30 minutes of standardized foot reflexology delivered by a certified practitioner. Participants continued their usual oncology treatment and supportive care. Pain intensity was assessed immediately before and within five minutes after each session. Receives: Other: Foot Reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-Session Change in Pain Intensity Measured by the Numerical Pain Rating Scale
Pain intensity was measured using the 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). We recorded scores immediately before and within five minutes after each foot reflexology session. We calculated within-session change as the pre-session score minus the post-session score, with positive values indicating reduced pain. Changes were assessed across 15 sessions.
Measured: Immediately before and within five minutes after each of 15 sessions over eight weeks.
Secondary outcomes (1)
Change in Pre-Session Pain Intensity Across the Foot Reflexology Program
We assessed pain intensity immediately before each session using the Numerical Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). We assessed pre-session scores across the 15-session program to describe changes over time. Lower scores indicate less pain.
Measured: Immediately before each of the 15 sessions over eight weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start7 Feb 2025
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawan AlAssaf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rawan AlAssaf, Al Al Bayt University, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916402
- Sponsor's protocol ID
- FR-PAIN-2025-01
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data with other researchers. Study findings will be reported in aggregate form in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pain Intensity During Home-Based Foot Reflexology in Patients With Advanced Cancer: A Prospective Study
- ClinicalTrials.gov ID
- NCT07916402
- Acronym / sponsor ID
- FR-PAIN-2025-01
- Conditions
- Cancer Pain, Advanced Cancer
- Keywords
- Foot Reflexology, Pain Management, Home-Based Intervention, Nonpharmacological Intervention, Supportive Cancer Care, Numerical Pain Rating Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rawan AlAssafUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 4 Nov 2026 (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 examined changes in pain during a home-based foot reflexology program for adults with advanced cancer in Jordan. Foot reflexology involves applying pressure to selected areas of the feet.
The main questions were:
- How did pain scores change immediately after each foot reflexology session?
- How did pain scores change over the eight-week program?
Participants received up to 15 at-home sessions over eight weeks, usually twice a week. Each session included 30 minutes of foot reflexology delivered by a trained, certified practitioner. Participants rated their pain from 0 (no pain) to 10 (worst possible pain) immediately before each session and within five minutes after.
All participants continued their usual cancer treatment and pain care. Everyone received foot reflexology; there was no separate comparison group. Researchers compared each participant's pain scores before and after sessions and across the program.
Detailed description
This prospective, single-group, nonrandomized interventional study included repeated pain assessments. Adults with advanced cancer and moderate-to-severe cancer-related pain were recruited through the outpatient pain and oncology clinics of a military oncology center in Amman, Jordan. Researchers delivered the intervention in participants' homes. The study had no concurrent control group, random allocation, or masking.
The study examined two patterns of pain change: immediate within-session changes and longitudinal changes during the intervention period. We assessed immediate changes by comparing pain scores recorded before and after each session. We assessed longitudinal changes by examining pre-session pain scores across the program.
The intervention followed a standardized Sorensensistem foot reflexology protocol. A certified reflexology practitioner delivered up to 15 sessions over eight weeks, generally twice weekly. Each home visit lasted approximately 40 minutes, including preparation and pre-session assessment, 30 minutes of manual foot reflexology, and post-session assessment and rest. Participants were instructed to report discomfort, which would prompt termination of the session.
Pain intensity was measured using the 11-point Numerical Pain Rating Scale, ranging from 0 (no pain) to 10 (worst possible pain). Assessments were completed immediately before each session and within five minutes after. We also collected baseline demographic and clinical information.
Participants continued their prescribed oncology treatment and supportive care. We documented changes in prescribed analgesics and cancer treatments during the intervention period. We provided foot reflexology as an adjunct to usual care, not as a replacement for prescribed treatment.
Pain assessments were limited to the eight-week intervention period. We conducted no follow-up assessments after the program ended. Because the study did not include a control group, we cannot determine whether foot reflexology itself caused the observed changes in pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-Based Foot Reflexology | Experimental | Other: Foot ReflexologyParticipants received up to 15 home-based foot reflexology sessions over eight weeks, generally twice weekly. Each session included 30 minutes of standardized foot reflexology delivered by a certified practitioner. Participants continued their usual oncology treatment and supportive care. Pain intensity was assessed immediately before and within five minutes after each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Diagnosis of advanced cancer, characterized using the tumor-node-metastasis (TNM) classification.
- Moderate-to-severe cancer-related pain, defined as a Numerical Pain Rating Scale (NPRS) score of 4 or higher, reported to the pain clinic.
Key exclusion criteria (6 listed)
- Gout.
- Leg ulcers.
- Peripheral vascular disease.
- Deep vein thrombosis.
- Infections, wounds, or bruises that could interfere with foot reflexology.
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 |
|---|---|---|
| Foot ReflexologyA certified practitioner delivered a standardized manual foot reflexology intervention following the Sorensensistem protocol in participants' homes. Treatment involved applying pressure to selected areas of the feet in a predefined sequence. Each treatment session lasted 30 minutes, and participants received up to 15 sessions over eight weeks, generally twice weekly. The intervention was provided alongside usual medical and oncology care. | Other | Home-Based Foot Reflexology |
Primary outcome
Within-Session Change in Pain Intensity Measured by the Numerical Pain Rating Scale
Time frame: Immediately before and within five minutes after each of 15 sessions over eight weeks.
Pain intensity was measured using the 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). We recorded scores immediately before and within five minutes after each foot reflexology session. We calculated within-session change as the pre-session score minus the post-session score, with positive values indicating reduced pain. Changes were assessed across 15 sessions.
1 secondary outcome
Change in Pre-Session Pain Intensity Across the Foot Reflexology Program
Time frame: Immediately before each of the 15 sessions over eight weeks.
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 4 Nov 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data with other researchers. Study findings will be reported in aggregate form in scientific publications.
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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 Foot Reflexology in people with Cancer Pain and Advanced Cancer, run by Rawan AlAssaf at 1 site in Jordan.
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 6 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 4 Nov 2026. 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 Jordan. 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?
Within-Session Change in Pain Intensity Measured by the Numerical Pain Rating Scale (time frame: Immediately before and within five minutes after each of 15 sessions over eight weeks.). 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 4 Nov 2026.