Trial Outcomes & Findings for Hand Reflexology for Fatigue and Anxiety in Hemodialysis Patients (NCT NCT07253831)
NCT ID: NCT07253831
Last Updated: 2026-05-13
Results Overview
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F, Version 4) is a validated 13-item questionnaire used to assess fatigue severity and its impact on quality of life over the past week. Each item is scored on a 5-point Likert scale (0 = "Not at all" to 4 = "Very much"). After reverse-scoring specific items, the total score ranges from 0 to 52, with higher scores indicating lower levels of fatigue. This measure will be administered to participants in both the intervention and control groups at three time points to evaluate the effect of Hand Reflexology Massage.
COMPLETED
NA
70 participants
4 weeks
2026-05-13
Participant Flow
Participant milestones
| Measure |
Hand Reflexology Massage
Participants in this group will receive standard hemodialysis care plus eight sessions of hand reflexology massage over four weeks. Each session, lasting 21 minutes, will be conducted twice a week during their dialysis treatment and will focus on specific reflex points-including the solar plexus, diaphragm line, adrenal glands, kidneys, pituitary gland, and heart point (on the left hand)-to promote relaxation and support symptom management for fatigue and anxiety.
|
Standard Care
Participants in this group will receive routine hemodialysis care only, without any additional hand reflexology massage. This includes standard nursing care, monitoring, and medical management as per the center's protocol. This group serves as a control to compare against the intervention group receiving hand reflexology.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
Baseline characteristics by cohort
| Measure |
Hand Reflexology Massage
n=35 Participants
Participants in this group will receive standard hemodialysis care plus eight sessions of hand reflexology massage over four weeks. Each session, lasting 21 minutes, will be conducted twice a week during their dialysis treatment and will focus on specific reflex points-including the solar plexus, diaphragm line, adrenal glands, kidneys, pituitary gland, and heart point (on the left hand)-to promote relaxation and support symptom management for fatigue and anxiety.
|
Standard Care
n=35 Participants
Participants in this group will receive routine hemodialysis care only, without any additional hand reflexology massage. This includes standard nursing care, monitoring, and medical management as per the center's protocol. This group serves as a control to compare against the intervention group receiving hand reflexology.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=35 Participants • The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
|
1 Participants
n=35 Participants • The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
|
2 Participants
n=70 Participants • The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=35 Participants • The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
|
32 Participants
n=35 Participants • The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
|
65 Participants
n=70 Participants • The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=35 Participants • The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
|
2 Participants
n=35 Participants • The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
|
3 Participants
n=70 Participants • The distribution of participants by sex reflects the natural allocation resulting from the computer-generated stratified randomization process (1:1) in this randomized controlled trial.
|
|
Sex: Female, Male
Female
|
10 Participants
n=35 Participants
|
12 Participants
n=35 Participants
|
22 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=35 Participants
|
23 Participants
n=35 Participants
|
48 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
FACIT-Fatigue Score at Baseline
|
24.4 Points on FACIT-Fatigue Scale
STANDARD_DEVIATION 10.1 • n=35 Participants
|
21.7 Points on FACIT-Fatigue Scale
STANDARD_DEVIATION 9.9 • n=35 Participants
|
23.1 Points on FACIT-Fatigue Scale
STANDARD_DEVIATION 10.1 • n=70 Participants
|
|
Beck Anxiety Inventory Score at Baseline Measure Type
|
20.7 Points on Beck Anxiety Inventory
STANDARD_DEVIATION 10.1 • n=35 Participants
|
23.6 Points on Beck Anxiety Inventory
STANDARD_DEVIATION 12.2 • n=35 Participants
|
22.2 Points on Beck Anxiety Inventory
STANDARD_DEVIATION 11.3 • n=70 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F, Version 4) is a validated 13-item questionnaire used to assess fatigue severity and its impact on quality of life over the past week. Each item is scored on a 5-point Likert scale (0 = "Not at all" to 4 = "Very much"). After reverse-scoring specific items, the total score ranges from 0 to 52, with higher scores indicating lower levels of fatigue. This measure will be administered to participants in both the intervention and control groups at three time points to evaluate the effect of Hand Reflexology Massage.
Outcome measures
| Measure |
Hand Reflexology Massage
n=35 Participants
Participants in this group will receive standard hemodialysis care plus eight sessions of hand reflexology massage over four weeks. Each session, lasting 21 minutes, will be conducted twice a week during their dialysis treatment and will focus on specific reflex points-including the solar plexus, diaphragm line, adrenal glands, kidneys, pituitary gland, and heart point (on the left hand)-to promote relaxation and support symptom management for fatigue and anxiety.
|
Standard Care
n=35 Participants
Participants in this group will receive routine hemodialysis care only, without any additional hand reflexology massage. This includes standard nursing care, monitoring, and medical management as per the center's protocol. This group serves as a control to compare against the intervention group receiving hand reflexology.
|
|---|---|---|
|
Change in Fatigue Levels as Measured by the Arabic FACIT-Fatigue Scale (FACIT-F)
Baseline (T0)
|
24.4 Points on FACIT-Fatigue Scale
Standard Deviation 10.1
|
21.7 Points on FACIT-Fatigue Scale
Standard Deviation 9.9
|
|
Change in Fatigue Levels as Measured by the Arabic FACIT-Fatigue Scale (FACIT-F)
Post-Intervention (T2)
|
29.5 Points on FACIT-Fatigue Scale
Standard Deviation 9.5
|
21.2 Points on FACIT-Fatigue Scale
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: 4 weeksThe Arabic version of the Beck Anxiety Inventory (Ar-BAI) is a 21-item self-report scale used to measure the severity of anxiety symptoms experienced in the past week. Each item is scored from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"), resulting in a total score ranging from 0 to 63. Higher scores indicate greater anxiety severity. This measure will be used to compare changes in anxiety between the two study groups across the same three assessment periods.
Outcome measures
| Measure |
Hand Reflexology Massage
n=35 Participants
Participants in this group will receive standard hemodialysis care plus eight sessions of hand reflexology massage over four weeks. Each session, lasting 21 minutes, will be conducted twice a week during their dialysis treatment and will focus on specific reflex points-including the solar plexus, diaphragm line, adrenal glands, kidneys, pituitary gland, and heart point (on the left hand)-to promote relaxation and support symptom management for fatigue and anxiety.
|
Standard Care
n=35 Participants
Participants in this group will receive routine hemodialysis care only, without any additional hand reflexology massage. This includes standard nursing care, monitoring, and medical management as per the center's protocol. This group serves as a control to compare against the intervention group receiving hand reflexology.
|
|---|---|---|
|
Change in Anxiety Levels as Measured by the Arabic Beck Anxiety Inventory (Ar-BAI)
Baseline (T0)
|
20.7 Points on Ar-BAI
Standard Deviation 10.1
|
23.6 Points on Ar-BAI
Standard Deviation 12.2
|
|
Change in Anxiety Levels as Measured by the Arabic Beck Anxiety Inventory (Ar-BAI)
Post-Intervention (T2)
|
12.8 Points on Ar-BAI
Standard Deviation 9.5
|
22.9 Points on Ar-BAI
Standard Deviation 11.8
|
Adverse Events
Hand Reflexology Massage
Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mr. Sabah Kareem Alshibli
Kufa University / College of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place