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Classic Foot Massage Applied to Preeclamptic Pregnants and Insomnia and Anxiety

Primary Purpose

Pregnant Women

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
massage
Sponsored by
Firat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnant Women

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Ayça Şolt Kirca
  • NURDİLAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

During the massage; A pillow will be placed under the patient's leg and a disposable cover will be placed on the pillow. During the massage, pregnant women will be massaged with baby oil or vaseline cream. The soles of the pregnant women will be rubbed by the practitioner's fingers. The practitioner will make circular movements by applying pressure to the sole of the pregnant woman's feet with her thumb, and will apply pressure to the foot with up and down movements, using the joint protrusions on the upper surface of the hand that she has made into a fist. The heel and ankle will be squeezed between the thumb and forefinger of the researcher and kneaded and the massage will be terminated.

no intervention will be made in the control group

Outcomes

Primary Outcome Measures

The State Anxiety Inventory (STAI-2):
The scale consists of twenty items and requires individuals to identify their feelings at a certain moment in particular situations and to answer the questions by considering how they feel about their current situation. Scores on the scale range between 20 and 80 1970. Öner and Le Compte (1974-1977) adapted the scale to Turkish culture and conducted its reliability and validity study [26]. The scale consists of twenty items and requires individuals to identify their feelings at a certain moment in particular situations and to answer the questions by considering how they feel about their current situation. Scores on the scale range between 20 and 80.

Secondary Outcome Measures

The Insomnia Severity Index
This seven-item scale was designed to identify the level of insomnia symptoms. It is utilized to screen the normal population and evaluate clinical insomnia [23-24]. Scores in the range of 0-4 are used to evaluate items on this 5-point Likerttype scale. Scores on the scale vary from 0 to 28, which are interpreted as follows: 0 to 7 refer to clinically insignificant insomnia; 8 to 14 refer to sub-threshold insomnia; 15 to 21 refer to moderate level of clinical insomnia; 22 to 28 refer to severe clinical insomnia

Full Information

First Posted
January 26, 2022
Last Updated
May 8, 2023
Sponsor
Firat University
Collaborators
ayça şolt kırca
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1. Study Identification

Unique Protocol Identification Number
NCT05231811
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Firat University
Collaborators
ayça şolt kırca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
During the massage; A pillow will be placed under the patient's leg and a disposable cover will be placed on the pillow. During the massage, pregnant women will be massaged with baby oil or vaseline cream. The soles of the pregnant women will be rubbed by the practitioner's fingers. The practitioner will make circular movements by applying pressure to the sole of the pregnant woman's feet with her thumb, and will apply pressure to the foot with up and down movements, using the joint protrusions on the upper surface of the hand that she has made into a fist. The heel and ankle will be squeezed between the thumb and forefinger of the researcher and kneaded and the massage will be terminated.
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention will be made in the control group
Intervention Type
Other
Intervention Name(s)
massage
Intervention Description
Pregnant women by the researcher; Foot massage consisting of classical massage techniques will be applied in a room in the clinic reserved for this application. During the massage; A pillow will be placed under the patient's leg and a disposable cover will be placed on the pillow. During the massage, pregnant women will be massaged with baby oil or vaseline cream. The soles of the pregnant women will be rubbed by the practitioner's fingers. The practitioner will make circular movements by applying pressure to the sole of the pregnant woman's feet with her thumb, and will apply pressure to the foot with up and down movements, using the joint protrusions on the upper surface of the hand that she has made into a fist. The heel and ankle will be squeezed between the thumb and forefinger of the researcher and kneaded and the massage will be terminated. During the application, the researcher who performs the massage will pay attention to the precautions applied in the hospital.
Primary Outcome Measure Information:
Title
The State Anxiety Inventory (STAI-2):
Description
The scale consists of twenty items and requires individuals to identify their feelings at a certain moment in particular situations and to answer the questions by considering how they feel about their current situation. Scores on the scale range between 20 and 80 1970. Öner and Le Compte (1974-1977) adapted the scale to Turkish culture and conducted its reliability and validity study [26]. The scale consists of twenty items and requires individuals to identify their feelings at a certain moment in particular situations and to answer the questions by considering how they feel about their current situation. Scores on the scale range between 20 and 80.
Time Frame
between 2 to 4 weeks
Secondary Outcome Measure Information:
Title
The Insomnia Severity Index
Description
This seven-item scale was designed to identify the level of insomnia symptoms. It is utilized to screen the normal population and evaluate clinical insomnia [23-24]. Scores in the range of 0-4 are used to evaluate items on this 5-point Likerttype scale. Scores on the scale vary from 0 to 28, which are interpreted as follows: 0 to 7 refer to clinically insignificant insomnia; 8 to 14 refer to sub-threshold insomnia; 15 to 21 refer to moderate level of clinical insomnia; 22 to 28 refer to severe clinical insomnia
Time Frame
betwee 2 to 4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant woman
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurdilan Şener
Organizational Affiliation
Firat University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AYÇA ŞOLT KIRCA
Organizational Affiliation
Kırklareli University
Official's Role
Study Director
Facility Information:
Facility Name
Ayça Şolt Kirca
City
Kırklareli
State/Province
Kirklareli̇
ZIP/Postal Code
39100
Country
Turkey
Facility Name
NURDİLAN
City
Elazığ
ZIP/Postal Code
23100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Classic Foot Massage Applied to Preeclamptic Pregnants and Insomnia and Anxiety

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