Efficacy of CES in New Mothers During the Post Partum Period

Stopped early · Not applicable · Has a placebo group

Conditions studied: Anxiety, Depression, Insomnia, Sleep Quality

In brief

The birth of a child is a major life event that can be filled with excitement, anticipation and joy. However, the transition and adaptation to new demands, roles, responsibilities, and changes in relationships can be stressful, especially for new mothers. In addition, new mothers typically encounter physiological changes and struggle with concerns about weight gain, body image, sexuality, and other physical difficulties such as fatigue. These problems may generate or exacerbate stress, lead to an actual or perceived crisis and psychological distress. Psychological distress, defined as anxiety, depression, and insomnia, in this study, often increases during the postpartum period and can negatively affect maternal mental health status, maternal and family relationships, and infant-child health. The purpose of this study is to evaluate the effects of cranial electrotherapy stimulation (CES) on anxiety, insomnia, depression, and maternal functioning in first time new mothers following childbirth.

Key facts

Study ID

NCT03210155

Run by

Christina Murphey, RN, PhD

People needed

1

Starts

2017-07-24

Expected to finish

2019-08-01

Last updated by the study team

2020-08-17

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Participant must have a total score of ≥ 16 on the HAM-A14 and ≥2 on both Hamilton Anxiety Rating Scale (HAM-A14) item 1 (anxious mood) and item 2 (tension) at screening and baseline to be considered for inclusion into the study.
• Participant is a primiparous new mother, 18-45 years inclusive, who had an uncomplicated vaginal or cesarean birth, gave birth to a healthy baby and both mother and baby are healthy at enrollment and randomization in the study.
• Sexually active female participants of childbearing potential must be self-report practicing, at least, one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception or abstinence. Female participants of childbearing potential must have a negative urine pregnancy test before receiving study treatment.
• Written informed consent must be obtained from the participant before study participation.
• Participant is in good medical health.
• No current abuse of alcohol or other substance.
• Capable of giving informed consent.
• Capable of doing active or sham CES treatments and completing all study requirements independently
• For compliance, participants need to have completed 85% (36) of treatments to continue participation in the study

You may not qualify if…

• Participant had serious complications during or after a vaginal or cesarean delivery.
• Participant had multiple births.
• Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for a mental disorder diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) as determined by medical history and/or self-report.
• Participant is clinically judged by the investigator to be at risk for suicide or is acutely suicidal. Participant has attempted suicide one or more times within the past twelve months.
• Participant has a Hamilton Anxiety Rating Scale (HAM-A14) score above 30 which suggests a very severe clinical level of anxiety symptoms.
• Participant has a Hamilton Depression Rating Scale (HAM-D17) score above 30 which suggests a very severe clinical level of depressive symptoms.
• Participant has a psychiatric condition that would require inpatient or partial psychiatric hospitalization.
• Participant has a significant history of medical disease (i.e. cardiovascular, hepatic (e.g., cirrhosis, hepatitis B or C) renal, gynecological, musculoskeletal, neurological (seizures), gastrointestinal, metabolic, hematological, endocrine, cancer with a metastatic potential or progressive neurological disorders) which could impair reliable participation in the trial or necessitate the use of medication not allowed by this protocol.
• Participant is pregnant, planning to become pregnant. If a participant becomes pregnant, she will be dropped from the study immediately and followed appropriately.
• Participant has had concomitant therapy with another investigational drug, or participation in an investigational drug study within one month before entering this study.
• Participant has a history of poor compliance or in the investigator's judgment any participant who is not compliant with the requirements of the study.
• Participant has had previous trial of CES.

Where it is running

• Primay care; OB-GYN Clinic — Austin, Texas, United States
• Primary care; OB-GYN Clinic — Corpus Christi, Texas, United States

Full record on ClinicalTrials.gov

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