Pregnant WomenNCT05231811
Classic Foot Massage Applied to Preeclamptic Pregnants and Insomnia and Anxiety
A study testing massage in people with Pregnant Women, run by Firat University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Jun 2022to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
NURDİLAN
Elâzığ, 23100
Ayça Şolt Kirca
Kırklareli, Kirklareli̇, 39100
About this study
Official title: The Effect of Classical Foot Massage on Insomnia and an Anxiety in Preeclamptic Pregnant Women: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Pregnant Women
- Being tested
- massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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. Receives: Other: massage |
| control group | No intervention | no intervention will be made in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between 2 to 4 weeks
Secondary outcomes (1)
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
Measured: betwee 2 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start3 Jun 2022
- Primary completion31 Dec 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Collaborators
- ayça şolt kırca
- Responsible party
- Principal investigator, NURDİLAN SENER, Firat University
- Investigators
- Nurdilan Şener, Principal investigator, Firat UniversityAYÇA ŞOLT KIRCA, Study director, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231811
- Sponsor's protocol ID
- firat universityyyyy
- Status last verified
- May 2023
- First submitted
- 26 Jan 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirca AS, Cetin NS. The effect of classical foot massage on insomnia and anxiety in preeclamptic pregnant women: a randomized controlled study. Rev Assoc Med Bras (1992). 2024 Feb 26;70(2):e20230744. doi: 10.1590/1806-9282.20230744. eCollection 2024.
PubMed 38422316
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Classical Foot Massage on Insomnia and an Anxiety in Preeclamptic Pregnant Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05231811
- Acronym / sponsor ID
- firat universityyyyy
- Conditions
- Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Collaborators
- ayça şolt kırca
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: massageDuring 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. |
| control group | No intervention | –no intervention will be made in the control group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massagePregnant 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. | Other | experimental group |
Primary outcome
The State Anxiety Inventory (STAI-2):
Time frame: between 2 to 4 weeks
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.
1 secondary outcome
The Insomnia Severity Index
Time frame: betwee 2 to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 38422316Kirca AS, Cetin NS. The effect of classical foot massage on insomnia and anxiety in preeclamptic pregnant women: a randomized controlled study. Rev Assoc Med Bras (1992). 2024 Feb 26;70(2):e20230744. doi: 10.1590/1806-9282.20230744. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurdilan Şener principal investigator
Firat University
AYÇA ŞOLT KIRCA study director
Kırklareli University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage in people with Pregnant Women, run by Firat University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The State Anxiety Inventory (STAI-2): (time frame: between 2 to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.