AnxietyNCT07878637
Foot Reflexology for Anxiety in Women Hospitalized With High-Risk Pregnancy
A study testing Foot Reflexology in people with Anxiety and Pregnancy, High-Risk, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Pregnancy, High-Risk, Pregnancy Complications
- What is being tested?
- Foot Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2026to 1 Apr 2029
- Phase
- Interventional
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Singleton pregnancy
- Gestational age of 24 weeks or more
- Hospitalized in the high-risk pregnancy unit for at least 24 hours
- Able to provide informed consent
Who cannot join
- Active labor
- Hemodynamic instability
- Foot pathology preventing reflexology
- Cognitive inability to complete questionnaires
- Reflexology received previously during the current admissio-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Edit Wolfson Medical Center
Holon
Julia Head of High risk pregnancy Unit, proffesor medical doctor, +972522548634, bardag@wmc.gov.il
About this study
Official title: Effect of Foot Reflexology on Anxiety Among Women Hospitalized in a High-Risk Pregnancy Unit: A Randomized Controlled Trial
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?
Read more
Researchers will also compare the two groups on self-rated anxiety (visual analog scale), blood pressure, heart rate, and satisfaction.
Participants will:
- Complete anxiety questionnaires and have their blood pressure and heart rate measured
- Be randomly assigned to either a 30-minute foot reflexology session given by a certified reflexologist, or a 30-minute rest period in a quiet environment (standard care)
- Repeat the questionnaires and measurements immediately afterwards and rate their satisfaction
Read the detailed description
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.
- Conditions
- Anxiety, Pregnancy, High-Risk, Pregnancy Complications
- Being tested
- Foot Reflexology
- Keywords
- reflexology foot reflexology complementary therapies antepartum hospitalization state anxiety STAI high-risk pregnancy
- Medical subject headings
- Anxiety Disorders, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot ReflexologyOther
Also called Reflexology
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.
| Study group | Role | What they receive |
|---|---|---|
| Foot Reflexology | Experimental | Participants receive a single 30-minute standardized foot reflexology session performed at the bedside by a certified reflexologist, in addition to standard care. Receives: Other: Foot Reflexology |
| Quiet Rest (Standard Care) | No intervention | Participants receive standard care and a 30-minute rest period in a quiet environment, matched in time to the reflexology session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (immediately before the session) and immediately after the 30-minute session
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline (immediately before the session) and immediately after the 30-minute session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to a single 30-minute foot reflexology session or a 30-minute quiet rest period, with assessments immediately before and immediately after.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamara Levy, Wolfson Medical Center
- Investigators
- Tamara Levy, Medical Doctor, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878637
- Sponsor's protocol ID
- 0123-26
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Yang JM, Li ZQ, Ye H, Wu YL, Long Y, Zhong YB, Luo Y, Wang MY. Effects of foot reflexology massage on pregnant women: a systematic review and meta-analysis of randomized controlled studies. Sci Rep. 2024 Jan 10;14(1):1012. doi: 10.1038/s41598-023-51107-y.
PubMed 38200035Wang WL, Hung HY, Chen YR, Chen KH, Yang SN, Chu CM, Chan YY. Effect of Foot Reflexology Intervention on Depression, Anxiety, and Sleep Quality in Adults: A Meta-Analysis and Metaregression of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2020 Sep 15;2020:2654353. doi: 10.1155/2020/2654353. eCollection 2020.
PubMed 33014101Wang MY, Tsai PS, Lee PH, Chang WY, Yang CM. The efficacy of reflexology: systematic review. J Adv Nurs. 2008 Jun;62(5):512-20. doi: 10.1111/j.1365-2648.2008.04606.x.
PubMed 18489444Kuehnle E, Jungk J, Brodowski L, Kohls F, Hillemanns P, Staboulidou I. Effects of Recreational Therapy and 3D Ultrasonography for High-Risk Pregnancies on Psychological Well-Being during Hospitalization and in the Puerperal Phase. J Clin Med. 2023 Sep 27;12(19):6228. doi: 10.3390/jcm12196228.
PubMed 37834871Toscano M, Royzer R, Castillo D, Li D, Poleshuck E. Prevalence of Depression or Anxiety During Antepartum Hospitalizations for Obstetric Complications: A Systematic Review and Meta-analysis. Obstet Gynecol. 2021 May 1;137(5):881-891. doi: 10.1097/AOG.0000000000004335.
PubMed 33831928