An interventional study of Foot Reflexology in Anxiety, Pregnancy, High-Risk and Pregnancy Complications, sponsored by Wolfson Medical Center. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Wolfson Medical Center · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to learn whether a single foot reflexology session reduces anxiety in pregnant women who are hospitalized in a high-risk pregnancy unit because of maternal or fetal complications.
The main question it aims to answer is: Do women who receive a 30-minute reflexology session have a greater reduction in state anxiety than women who have a 30-minute quiet rest?
Researchers will also compare the two groups on self-rated anxiety (visual analog scale), blood pressure, heart rate, and satisfaction.
Participants will:
Background Hospitalization during pregnancy for maternal or fetal complications is frequently associated with psychological distress, particularly anxiety. Women admitted to high-risk pregnancy units face uncertainty about pregnancy outcomes, concern for maternal and fetal well-being, prolonged hospitalization, loss of daily routines, and reduced social support. Reflexology is a non-invasive complementary therapy that applies pressure to specific points on the feet. Proposed mechanisms include modulation of the autonomic nervous system, stimulation of neural pathways, hemodynamic changes, and endorphin release. Reflexology has been associated with reduced anxiety in several clinical settings and, in pregnancy, with reduced anxiety and pain during labor. Its effect on women hospitalized in high-risk pregnancy units has not been studied.
Design Prospective, single-center, randomized controlled trial with 1:1 allocation to reflexology or quiet rest.
Procedures Baseline (T0, immediately before the session): blood pressure, heart rate, State-Trait Anxiety Inventory state subscale (STAI-S), and anxiety visual analog scale (VAS, 0-10).
Intervention: a single 30-minute standardized foot reflexology session by a certified reflexologist, or a 30-minute quiet rest period (standard care).
Post-intervention (T1, immediately after): blood pressure, heart rate, STAI-S, VAS anxiety, and a satisfaction questionnaire.
Statistical analysis Continuous variables will be summarized as mean ± SD or median (IQR). Between-group comparisons will use the independent t-test or Mann-Whitney U test; within-group comparisons will use the paired t-test or Wilcoxon signed-rank test. The correlation between changes in VAS and STAI-S will be assessed with Pearson or Spearman coefficients. Exploratory subgroup analyses by indication for hospitalization are planned. A two-sided p \< 0.05 will be considered significant.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 144 is above the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Wolfson Medical Center is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive a single 30-minute standardized foot reflexology session performed at the bedside by a certified reflexologist, in addition to standard care.
Other: Foot Reflexology
Participants receive standard care and a 30-minute rest period in a quiet environment, matched in time to the reflexology session.
A single 30-minute standardized session of manual pressure applied to reflex points on both feet while patient is lying down, performed by a certified reflexologist.
Also known as: Reflexology
Change in State Anxiety (STAI-S) Score
State anxiety measured with the state subscale of the State-Trait Anxiety Inventory (STAI-S; 20 items, total score 20-80, higher scores indicate greater anxiety). Change is calculated as the post-intervention score minus the baseline score.
Time frame: Baseline (immediately before the session) and immediately after the 30-minute session
Change in Anxiety Visual Analog Scale (VAS) Score
Self-rated anxiety on a 0-10 visual analog scale (0 = no anxiety, 10 = worst possible anxiety). Change is calculated as post-intervention minus baseline.
Time frame: Baseline (immediately before the session) and immediately after the 30-minute session
Change in Systolic Blood Pressure
Systolic blood pressure in mmHg. Change is calculated as post-intervention minus baseline.
Time frame: Baseline (immediately before the session) and immediately after the 30-minute session
Change in Diastolic Blood Pressure
Diastolic blood pressure in mmHg. Change is calculated as post-intervention minus baseline.
Time frame: Baseline (immediately before the session) and immediately after the 30-minute session
Change in Heart Rate
Heart rate in beats per minute. Change is calculated as post-intervention minus baseline.
Time frame: Baseline (immediately before the session) and immediately after the 30-minute session
Participant Satisfaction
Satisfaction with the session was measured using two items rated from 1 to 5 (higher scores indicating greater satisfaction): overall satisfaction with the session, and willingness to recommend it to other women in a similar situatio
Time frame: Immediately after the 30-minute session
Correlation Between Change in STAI-S and Change in VAS Anxiety
Pearson or Spearman correlation coefficient between the change in STAI-S score and the change in VAS anxiety score, calculated across all participants.
Time frame: Baseline (immediately before the session) and immediately after the 30-minute session
Plan to share: No — De-identified individual participant data will not be publicly shared. Data may be made available by the principal investigator on reasonable request and subject to ethics committee approval.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 24 months is above that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.