The efficacy of electrical stimulation to control the symptoms of nausea and vomiting in pregnant women.

TENS efficacy on the control of nausea, vomiting and hyperemesis gravidarum in pregnant women: a randomized, blind, placebo-controlled clinical trial.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-9z5t9q

Enrollment

Unknown

Registered

2019-07-09

Start date

2019-08-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea

Interventions

Two intervention groups will be performed with electro-stimulator previously programmed to perform TENS (G_TENS) and TENS-placebo (G_TENS_P). Initially, each group will have 30 participants, both gro

Device

E02.331.800

H02.004

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant women with symptoms of nausea (defined as an uncomfortable sensation associated with a desire to vomit), vomiting (defined as oral expulsion of gastric contents), and hyperemesis (characterized by persistent nausea and vomiting leading to dehydration, ketosis, (with a weight loss greater than 5% of the total weight), triggered during gestation, which compromise women's quality of life (classified with a minimum of 3 points evaluated by numerical scale of 0 to 10 points); aged 18 years or over and medical follow-up during prenatal care.

Exclusion criteria

Exclusion criteria: Alteration of pain and tactile sensitivity (assessed by Buck hammer needle test and esthesiometer) or presence of skin lesion in the upper limbs; Presence of a cardiac pacemaker; Gestation of risk; Carriers of neurological abnormalities; cardiopathies; cognitive disorders and physical limitations that make it impossible to participate in the study.

Design outcomes

Primary

Measure	Time frame
To assess the presence and severity of nausea and vomiting using a questionnaire translated into Portuguese, "Modified Pregnancy-Unique Quantification of Emesis and Nausea (Modified-PUQE)": with a variable score of 3 to 15, the higher the score higher the severity. (LACASSE et al., 2008).;To evaluate the quality of life impairment by means of a questionnaire translated into the Portuguese language "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy (NVP-QOL)": with variable score from 30 to 210, the higher the highest score commitment. (LACASSE; BÉRARD, 2008);To evaluate the presence and severity of nausea by numerical scale, classifying from 0 to 10 the impact of the treatment on the symptoms of nausea and vomiting. (Note 0 should be attributed to "absence of nausea and vomiting" and note 10 "presence of severe nausea and vomiting", investigated before and immediately after the intervention - immediate efficacy (EVA_imed) and each treatment week - late EVA_tard).	—

Measure

Time frame

To assess the presence and severity of nausea and vomiting using a questionnaire translated into Portuguese, "Modified Pregnancy-Unique Quantification of Emesis and Nausea (Modified-PUQE)": with a variable score of 3 to 15, the higher the score higher the severity. (LACASSE et al., 2008).;To evaluate the quality of life impairment by means of a questionnaire translated into the Portuguese language "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy (NVP-QOL)": with variable score from 30 to 210, the higher the highest score commitment. (LACASSE; BÉRARD, 2008);To evaluate the presence and severity of nausea by numerical scale, classifying from 0 to 10 the impact of the treatment on the symptoms of nausea and vomiting. (Note 0 should be attributed to "absence of nausea and vomiting" and note 10 "presence of severe nausea and vomiting", investigated before and immediately after the intervention - immediate efficacy (EVA_imed) and each treatment week - late EVA_tard).

—

Secondary

Measure	Time frame
To evaluate medication intake (indicated by the obstetrician), through medication control completed by the participant. ;To evaluate the personal satisfaction with the proposed treatment, performed at the end of the treatment, in a computerized program, without the presence of the researchers involved.	—

Countries

Brazil

Contacts

Public ContactAdriana;Simone Piccini;Pereira

Universidade Federal de Alfenas;Universidade Federal de Alfenas

dripiccini@hotmail.com;simone.botelho@unifal-mg.edu.br+55-35-99743-3342;+55-35-3701-1928

Outcome results

None listed

Source: REBEC (via WHO ICTRP)