Fatigue, Anxiety, and Mother-Baby Bonding and Emotional Freedom Technique

NCT06997211 | Not Yet Recruiting DMC

• 2 other identifiers: E-54022451-050.04-171619MMeseduzu
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fatigue, Anxiety, and Mother-Baby Bonding and Emotional Freedom Technique

Conditions

Puerperium; EFTs

Keywords

EFT; PRETERM INFANT; ANXIETY; MOTHER-BABY BONDING; FATIGUE; PUERPERIUM

Outcome Measures

Primary Outcomes (3)

• Fatigue, Anxiety, and Mother-Baby Bonding and Effect of the Emotional Freedom

  1\. Visual Similarity Scale for Fatigue (VSSF): This is a visual analog scale designed to assess an individual's subjective level of fatigue. Participants are presented with a straight line anchored by the descriptors "not at all fatigued" (0 points) on one end and "extremely fatigued" (10 points) on the other. Participants are asked to mark the point on the line that best represents their current fatigue level. Scores range from a minimum of 0 to a maximum of 10. Higher scores indicate a higher level of perceived fatigue. This scale is widely used in clinical settings due to its simplicity and efficiency.

  2 year

• Fatigue, Anxiety, and Mother-Baby Bonding and Effect of the Emotional Freedom

  2.State-Trait Anxiety Inventory (STAI-II) The State-Trait Anxiety Inventory (STAI-II) consists of two subscales that measure state and trait anxiety, each using a four-point Likert-type response format. In the State Anxiety Scale, the response options are: (1) Not at all, (2) Somewhat, (3) Moderately so, and (4) Very much so. In the Trait Anxiety Scale, the options are: (1) Almost never, (2) Sometimes, (3) Often, and (4) Almost always. Higher scores on the inventory indicate a higher level of anxiety. The total score obtained from the scale ranges between 20 and 80. Scores between 20 and 39 indicate mild anxiety, scores between 40 and 59 indicate moderate anxiety, scores between 60 and 79 indicate high anxiety, and a score of 80 indicates a panic-level anxiety.

  2 year

• Fatigue, Anxiety, and Mother-Baby Bonding and Effect of the Emotional Freedom

  3.Mother-Infant Bonding Scale (MIBS) The Mother-Infant Bonding Scale is designed to be used from the very first day after birth and allows the mother to describe her feelings toward her baby in a single word. The scale consists of 8 items and is structured as a 4-point Likert-type scale. Each item is rated using four response options ranging from (0) Very much to (3) Never. Items 1, 4, and 6 reflect positive emotions and are scored as 0, 1, 2, 3 respectively. Items 2, 3, 5, 7, and 8 reflect negative emotions and are reverse scored as 3, 2, 1, 0. The total score ranges from 0 to 24, with higher scores indicating more negative effects on bonding between the mother and the baby.

  2 year

Study Arms (2)

EXPERİMENTAL: EFT GROUP

EXPERIMENTAL

Steps for the Intervention Group: Pre-Intervention: * Participants in the intervention group will be informed about EFT, and after explaining the aim and method of the study, their consent will be obtained using the Volunteer Consent Form. * They will complete the State-Trait Anxiety Inventory (STAI), and those who score 40 or higher will be included in the study. * Afterward, information will be provided about EFT, including how the procedure will be performed and how tapping will be done. Following a discussion planned to last approximately 20 minutes, the EFT session will begin. * Prior to the intervention, women will be asked to fill out the Descriptive Information Form, State-Trait Anxiety Inventory (STAI-I), Visual Similarity Scale for Fatigue (YİGBS), and Mother-Infant Bonding Scale (MIBS) forms. 1\. EFT Procedure Sequence: * The first meeting will be conducted within the first 24 hours after the admission of mothers who meet the inclusion criteria for our study in the NICU. * T

Behavioral: EFT

CONTROL GROUP

NO INTERVENTION

Control Group Application Steps: Control Group 1st Meeting (Pre-test): The mothers in the control group, who have premature babies in the neonatal intensive care unit, will be informed about the study. After explaining the purpose and method of the study, their consent will be obtained through the Volunteer Consent Form. The women will complete the forms, and those with a score of 40 or above will be included in the study. The women in the control group will be asked to complete the Descriptive Information Form, State-Trait Anxiety Inventory (STAI I-II), Visual Similarity Scale for Fatigue (YİGBS), and Mother-Infant Bonding Scale (MIBS) forms. No intervention will be provided for the mothers in the control group, but the institution's neonatal intensive care services will be available to them. Control Group 2nd Meeting: One week after the first meeting, the State-Trait Anxiety Inventory (STAI I-II), Visual Similarity Scale for Fatigue (YİGBS), and Mother-Infant Bonding Scale (MIBS) fo

Interventions

EFT BEHAVIORAL

The EFT session will be conducted mutually with the practitioner. The average duration of the session is planned to be 40-45 minutes.

Also known as: EFT AND PUERPERIUM

EXPERİMENTAL: EFT GROUP

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: puerperıum
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those who can read and write and who can speak and understand Turkish,
• Those whose STAI-I (status) score range is 40 and above
• Mothers whose babies were born prematurely
• Mothers whose babies are in NICU,
• Mothers who agreed to participate in the study.

You may not qualify if:

• Mothers of premature newborns who cannot be fed with breast milk,
• Mothers who were discharged during the study sessions and did not agree to continue working,
• The mother has any cognitive or hearing-related problems,
• The mother has a psychiatrically diagnosed disease (Schizophrenia, bipolar disorder, depression).
• Having epilepsy (since it is contraindicated for EFT applications)

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Premature Birth; Anxiety Disorders; Fatigue

Interventions

Postpartum Period

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• HANDAN ÖZCAN, Associate Professor

  HAMİDİYE HEALTH SCİENCE UNIVERSTY

  STUDY DIRECTOR

Central Study Contacts

MERVE MESEDUZU, LECTURER

CONTACT

+905458171926; mmeseduzu@bezmialem.edu.tr

HANDAN ÖZCAN Associate Professor, ACADEMİCİAN

CONTACT

05370155030

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Model Details: 1\. EFT Procedure Sequence: • The first meeting will be conducted within the first 24 hours after the admission of mothers who meet the inclusion criteria for our study in the NICU.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: May 30, 2025
• Study Start: June 20, 2025
• Primary Completion: January 20, 2026
• Study Completion: March 20, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share