Clinical trial NCT05231811: Classic Foot Massage Applied to Preeclamptic Pregnants and Insomnia and Anxiety
Official title: The Effect of Classical Foot Massage on Insomnia and an Anxiety in Preeclamptic Pregnant Women: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women
Lead sponsor: Firat University
Sponsor class: OTHER
Collaborators: name: ayça şolt kırca
First posted: 2022-02-09
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Preeclampsia affects the sleep quality of pregnant women. With this study, it is expected that the sleep quality will be regulated by applying massage to pregnant women.

Detailed description: One of the most important life events that cause change in a woman's life is the experience of pregnancy and childbirth. Pregnancy is a natural process for a woman; However, many women die due to complications during pregnancy. Severe hypertension is among the main causes of maternal and infant mortality during pregnancy and postpartum period. Hypertension in pregnancy occurs in 12-15% of all pregnancies, of which approximately 70% is preeclampsia and the remainder is chronic hypertension. It can cause severe hypertension, ablatio placenta, cerebral hemorrhage, pulmonary edema, liver and kidney failure, stroke, hemorrhage, intrauterine fetal death, HELLP (hemolysis, increased liver enzymes, low platelet) syndrome and maternal death in preeclamptic pregnant women. There is a relationship between hypertension and sleep disorders during pregnancy, . It has been reported that some sleep problems such as insomnia, fragmented sleep, snoring, sleep apnea and non-idiopathic insomnia are more common in pregnant women with preeclampsia than healthy pregnant women. Sleep disorders are associated with both increased morbidity and mortality. Poor sleep quality also increases the risk of depression. Sleep disorders also affect cardiovascular morbidity, including neuroendocrine, metabolic and inflammatory systems. Short sleep duration in pregnancy is also associated with longer delivery times and increased cesarean rates. Similarly, sleep problems experienced during pregnancy, poor sleep quality and stress may cause prolongation of labor, more fatigue of the mother during labor, development of complications, and increased fear and anxiety of the mother; It can lead to inadequate care of pregnant women, increase in the incidence of glucose intolerance and gestational diabetes, preterm delivery, delivery of a low-birth-weight baby and developmental problems in the baby. Moreover , it has been determined that the 3rd trimester sleep quality score is also associated with postpartum depressive symptoms . All these results show the importance of sleep for a healthy pregnancy. Various ways of coping are sought to solve sleep problems during pregnancy. These include lip exercises and diaphragmatic breathing exercises, training programs, yoga, passive exercises, and footbathing. In addition, it has been reported that applying foot massage to pregnant women with physiological edema in the lower extremities relieves insomnia complaints. It has been observed in the literature that classical foot massage performed in different disease groups reduces sleep symptoms. However, no study has been found in the literature examining the effect of classical foot massage applied to pregnant women with preeclampsia on insomnia. The aim of this study is to determine the effect of classical foot massage applied to preeclamptic pregnant women on sleep symptoms. If classical foot massage reduces insomnia symptoms, the effectiveness of a non-pharmacological method in reducing insomnia symptoms of preeclamptic pregnant women has been evaluated, and it is thought that a new approach will be presented both to the literature and to basic care interventions.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with preeclampsia
* Not having been diagnosed with pre-pregnancy sleep and not using one of the pharmacological or non-pharmacological treatment methods
* not using any medication for sleep

Exclusion Criteria:

* Having a history of psychiatric illness or receiving psychiatric treatment (Pharmacotherapy or psychotherapy) Pregnant women hospitalized for less than 1 week
* Having a chronic disease other than preeclampsia (Diabetes, Thyroid dysfunction, Cardio vascular problem, etc.)
* Pregnant women who lost their baby during the research period
* Obstetric or non-obstetric complications,
* Having any problem that prevents communication (such as not knowing Turkish, having a hearing, speaking and understanding disorder)

Primary outcomes:
measure: The State Anxiety Inventory (STAI-2):
timeFrame: between 2 to 4 weeks
Secondary outcomes:
measure: The Insomnia Severity Index
timeFrame: betwee 2 to 4 weeks
Other outcomes:
Locations:
city: Kırklareli
country: Turkey
facility: Ayça Şolt Kirca
state: Kirklareli̇
city: Elazığ
country: Turkey
facility: NURDİLAN
Study officials:
affiliation: Firat University
name: Nurdilan Şener
role: PRINCIPAL_INVESTIGATOR
affiliation: Kırklareli University
name: AYÇA ŞOLT KIRCA
role: STUDY_DIRECTOR
References: