Emotional Freedom Techniques (EFT) and Postpartum Depression

NCT04355091 | Completed

• 1 other identifier: 99984023-302.99-
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis 1: Pregnant women in the EFT group will have a lower test score from Edinburgh Postpartum Depression Scale, and a follow-up score of three months and six months after the last application date, compared to the control group. Hypothesis 2: In the post-test of pregnant women in the EFT group, three months and six months after the last application date, the optimistic, self-confident and social support approach methods used to deal with stress will increase, and the helpless and submissive approach styles will decrease compared to the control group. Hypothesis 3: Pregnant women in the EFT group will have a lower test score from the State-Trait Anxiety Inventory, and a follow-up score of three months and six months after the last application date, compared to the control group.

Conditions

Postpartum Depression

Keywords

postpartum depression; pregnancy; stress

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Edinburgh Postpartum Depression Scale scores at 6 months

  The scale consists of 10 items. Items are evaluated in 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0, the highest score is 30. Each item is scored as 0,1,2,3 in the scale. In the evaluation of 3,5,6,7,8,9,10 items, the scoring is reversed (3,2,1,0). Individuals with a total scale score higher than the cut-off point are considered a risk group for depression. The cut-off score was taken as 12 in this study.

  Baseline and 6 months

Secondary Outcomes (2)

• Stress Coping Styles Scale

  Change from baseline in stress coping styles at 6 months

• State-Trait Anxiety Inventory

  Change from baseline in State-Trait Anxiety scores at 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The pregnant women in this group will be informed about the application of EFT with a written material. The pregnant women who have undergone EFT will be interviewed a week or two after the application, and how they feel and whether the problem still disturbs him. If a new issue is reported, similar actions will be repeated for this new issue. The number of EFT sessions was decided based on the condition of the pregnant woman. After all EFT sessions are completed, a re-evaluation (post-test) of Edinburgh Postpartum Depression Scale, Stress Coping Scale and State-Trait Anxiety Inventory will be done. The same participants will be asked to apply the other inventories and the postpartum interview form if she had birth three months and six months after the last application (follow-up). In the follow-up study performed three months after the last application, EFT will be applied to the pregnant women in need.

Behavioral: Emotional Freedom Techniques (EFT)

control group

NO INTERVENTION

The participants in this group will be talked about the problems they should have in routine midwifery care, the problems they encounter during pregnancy or postpartum period and the subjects they want to receive information. If necessary, suggestions will be made for problems related to pregnancy, postpartum period or newborn care. Again, with these participants, after the depression risk determination (pre-test), after the interviews ended (post-test), three months and six months after the last application, Edinburgh Postpar All Depression Scale, Stressful Life Events List, Stress Coping Scale. If the pregnant woman has given birth, State-Trait Anxiety Inventory and postnatal interview form will be performed.

Interventions

Emotional Freedom Techniques (EFT) BEHAVIORAL

It combines cognitive therapy, acceptance and stability therapy, and acupuncture point stimulation, and is based on manual stimulation of acupuncture points specific to Shiatsu or other acupressure massage forms, rather than using acupuncture needles.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be in the 18-49 age range
• To be at least a primary school graduate
• To be pregnant between 13-30 weeks
• Not having a risky pregnancy,
• Having spontaneous pregnancy,
• Having a single and live fetus
• Not having a chronic serious physical illness or disability
• The absence of infection, wound, scar in the tapping area

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Cerrahpaşa

Istanbul, Eyalet/Yerleşke, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Neslihan Ozcan, Professor

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: In order to determine the risk of depression, the Edinburgh Postpartum Depression Scale (EPDS) will be administered to the pregnant women. Pregnant women who receive 12 ≥ points from the EPDS will be included in the randomization process. Subsequently, the tests will be applied to experimental and control groups. EFT will be applied to women in the experimental group. One or two weeks after the application, it will be discussed again and questioned how she feels, whether that problem still disturbs her. The number of EFT sessions can be increased or decreased depending on the condition of the woman (the average number of sessions reported in the studies ranges from 2-10). After all EFT sessions are completed, three months and six months after the last application, post-tests will be done. the control group will receive routine midwifery care. The post-tests will be done by the control group after three months and six months

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 21, 2020
• Study Start: July 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: April 30, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)