Trial Outcomes & Findings for the Effect of Reflexology in Migraine Patients (NCT NCT06828315)

NCT ID: NCT06828315

Last Updated: 2026-03-04

Results Overview

Pain intensity was assessed using the Visual Analog Scale (VAS) for Pain. The Visual Analog Scale is a unidimensional measure of perceived pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" (0) and "worst imaginable pain" (10). Participants mark a point on the line corresponding to their perceived pain intensity, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain severity and represent a worse outcome. Lower scores indicate less pain and represent a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

At the end of the 5-week intervention

Results posted on

2026-03-04

Participant Flow

Participant milestones

Participant milestones
Measure
Experimental Group
reflexology was applied to the experimental group Reflexology: Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet.
Control Group
reflexology was not applied to the control group
Pre-Intervention (Baseline)
STARTED
39
39
Pre-Intervention (Baseline)
COMPLETED
39
39
Pre-Intervention (Baseline)
NOT COMPLETED
0
0
Post-Intervention (At the End of Week 5)
STARTED
39
39
Post-Intervention (At the End of Week 5)
COMPLETED
39
39
Post-Intervention (At the End of Week 5)
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Experimental Group
n=39 Participants
reflexology was applied to the experimental group Reflexology: Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet.
Control Group
n=39 Participants
reflexology was not applied to the control group
Total
n=78 Participants
Total of all reporting groups
Age, Continuous
42.76 Year
STANDARD_DEVIATION 12.23 • n=39 Participants
38.41 Year
STANDARD_DEVIATION 10.63 • n=39 Participants
40.58 Year
STANDARD_DEVIATION 11.59 • n=78 Participants
Sex: Female, Male
Female
25 Participants
n=39 Participants
24 Participants
n=39 Participants
49 Participants
n=78 Participants
Sex: Female, Male
Male
14 Participants
n=39 Participants
15 Participants
n=39 Participants
29 Participants
n=78 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Baseline Pain Intensity (Visual Analog Scale)
7.26 Score (range 0-10)
STANDARD_DEVIATION 1.48 • n=39 Participants
7.59 Score (range 0-10)
STANDARD_DEVIATION 1.25 • n=39 Participants
7.42 Score (range 0-10)
STANDARD_DEVIATION 1.37 • n=78 Participants
Baseline Fatigue Severity
43.77 Score (9-63)
STANDARD_DEVIATION 5.11 • n=39 Participants
43.10 Score (9-63)
STANDARD_DEVIATION 5.73 • n=39 Participants
43.43 Score (9-63)
STANDARD_DEVIATION 5.41 • n=78 Participants
Baseline Migraine-Specific Quality of Life
68.15 Score (15-105)
STANDARD_DEVIATION 8.27 • n=39 Participants
67.59 Score (15-105)
STANDARD_DEVIATION 6.01 • n=39 Participants
67.87 Score (15-105)
STANDARD_DEVIATION 7.18 • n=78 Participants

PRIMARY outcome

Timeframe: At the end of the 5-week intervention

Pain intensity was assessed using the Visual Analog Scale (VAS) for Pain. The Visual Analog Scale is a unidimensional measure of perceived pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" (0) and "worst imaginable pain" (10). Participants mark a point on the line corresponding to their perceived pain intensity, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain severity and represent a worse outcome. Lower scores indicate less pain and represent a better outcome.

Outcome measures

Outcome measures
Measure
Experimental Group
n=39 Participants
reflexology was applied to the experimental group Reflexology: Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet.
Control Group
n=39 Participants
reflexology was not applied to the control group
Visual Analog Scale (VAS)
4.15 Score (0-10)
Standard Deviation 1.63
7.46 Score (0-10)
Standard Deviation 1.48

PRIMARY outcome

Timeframe: At the end of the 5-week intervention

The Fatigue Severity Scale (FSS) will be used to evaluate changes in participants' fatigue levels. The FSS consists of nine items scored from 1 to 7, with higher scores indicating greater fatigue severity. The total score ranges from a minimum of 9 to a maximum of 63.

Outcome measures

Outcome measures
Measure
Experimental Group
n=39 Participants
reflexology was applied to the experimental group Reflexology: Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet.
Control Group
n=39 Participants
reflexology was not applied to the control group
Fatigue Severity Scale (FSS)
32.97 Score (9-63)
Standard Deviation 6.74
42.28 Score (9-63)
Standard Deviation 6.39

PRIMARY outcome

Timeframe: At the end of the 5-week intervention

24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ) will assess changes in migraine-specific quality of life. It includes five subscales: Migraine Symptoms, Emotions and Concerns, Work Functionality, Social Functionality, and Energy/Vitality. Higher scores indicate better quality of life. The total score ranges from a minimum of 15 to a maximum of 105.

Outcome measures

Outcome measures
Measure
Experimental Group
n=39 Participants
reflexology was applied to the experimental group Reflexology: Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet.
Control Group
n=39 Participants
reflexology was not applied to the control group
24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ)
81.05 Score (15-105)
Standard Deviation 8.97
69.51 Score (15-105)
Standard Deviation 8.99

Adverse Events

Experimental Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant Professor Cihat DEMİREL

Muş Alparslan University

Phone: +90 5536186477

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place