Classic Foot Massage Applied to Preeclamptic Pregnants and Insomnia and Anxiety

NCT05231811 | Completed

• 1 other identifier: firat universityyyyy
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

• 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.

  between 2 to 4 weeks

Secondary Outcomes (1)

• The Insomnia Severity Index

  betwee 2 to 4 weeks

Study Arms (2)

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.

Other: massage

control group

NO INTERVENTION

no intervention will be made in the control group

Interventions

massage OTHER

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Firat University: lead
• ayça şolt kırca: collaborator

Study Sites (2)

Ayça Şolt Kirca

Kırklareli, Kirklareli̇, 39100, Turkey (Türkiye)

Location

NURDİLAN

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38422316 DERIVED

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nurdilan Şener

  Firat University

  PRINCIPAL INVESTIGATOR

• AYÇA ŞOLT KIRCA

  Kırklareli University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asssistant professor

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 9, 2022
• Study Start: June 3, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 20, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)