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Recruiting NCT07880587

Reflexology Hand Massage After Cesarean Section

Conditions: Cesarean Section, Anxiety, Postoperative Period

Sex: Female
Ages: 20 Years – 35 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Dokuz Eylul University

Location: Dokuz Eylul University Research and Application Hospital Izmir

Summary

Background: Globally, cesarean section (CS) rates are rapidly increasing. Although cesarean delivery is a life-saving surgical intervention, it can lead to adverse outcomes such as anxiety, decreased maternal satisfaction, and alterations in hemodynamic parameters. Hand massage, as a complementary nursing intervention, is considered an effective method for alleviating these issues by promoting physiological and psychological well-being. Objective: The aim of this study is to examine the effects of reflexology hand massage and stroking hand massage on anxiety, satisfaction, and hemodynamic parameters in women during the early postoperative period following a cesarean section. Methods: This study is designed as a single-blind, randomized, placebo-controlled trial. The study population will consist of women who undergo cesarean delivery and are hospitalized in the Obstetrics and Gynecology Ward of Dokuz Eylul University Research and Application Hospital. The study sample will include women aged 20-35 years who undergo a term, elective cesarean delivery between April 2026 and January 2027, and are at their 4th postoperative hour. The experimental group will receive a 20-minute reflexology hand massage, while the control group will receive a 20-minute stroking hand massage (placebo). Due to the single-blind nature of the study, participants will only be informed that they will receive a "hand massage," without specifying the exact technique (reflexology or stroking). Satisfaction will be measured using a Visual Analog Scale (VAS), and anxiety will be measured using the State Anxiety Inventory (STAI) before the intervention and 30 minutes after the massage application. Data obtained from the study will be analyzed using the SPSS (IBM SPSS Statistics, Version 25) software. Descriptive statistics will be presented as mean, standard deviation, and median (minimum-maximum) for continuous variables, and as frequencies and percentages for categorical variables. The conformity of the data to normal distribution will be evaluated using the Kolmogorov-Smirnov and Shapiro-Wilk tests. For the comparison of continuous variables between groups, the Independent Samples t-test will be used for normally distributed data, and the Mann-Whitney U test for non-normally distributed data. For within-group comparisons of time-dependent measurements, Repeated Measures ANOVA will be applied if the normality assumption is met, whereas the Friedman test will be used if it is not met. To compare time-dependent changes between groups, a two-way repeated measures ANOVA will be utilized for normally distributed data, and Generalized Linear Models or appropriate non-parametric methods will be employed for non-normally distributed data. Categorical variables will be compared using the Chi-square test or Fisher's Exact test when necessary. The statistical significance level will be set at p \< 0.05 for all analyses.

Eligibility Criteria

Inclusion Criteria: * Women aged between 20 and 35 years. * Underwent an elective term cesarean delivery. * Having a healthy newborn with a 1-minute Apgar score \> 7. * Being at the 4th postoperative hour. * No diagnosed psychological disorders (such as depression or anxiety disorder). * Not using any anxiolytic medications. * Having no contraindications for hand massage (i.e., absence of skin lesions, burns, or musculoskeletal pathologies on the hands). Exclusion Criteria: * Development of severe postoperative complications (e.g., excessive bleeding, infection). * Conditions requiring admission to the Intensive Care Unit (ICU). * Presence of postnatal complications. * Having chronic or ongoing systemic diseases. * Having any skin lesions, burns, open wounds, or musculoskeletal pathologies on the hands. * Inability to speak and understand Turkish.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07880587). StuddyBuddy aggregates publicly available trial information.