Study design
This two-armed pilot study had an intervention and a control group, with participants allocated to each group in a 1:1 ratio. The CONSORT guidelines for pilot and feasibility study were adhered to [11]. The study was conducted in a gynaecological clinic in a community hospital located in southwest Sweden. Patients are referred to the hospital from primary care clinics, maternal health clinics or other hospitals in the region, and may also request care from the clinic by self-referral.
The study was registered in de Research Database Registry in Västra Götalandsregionen (Sweden) with number: 254161 on 10 November 2018.
Participants
Patients who attended the clinic between October 2018 to April 2020 were eligible for the study if they were at least 18 years old and had one of the following indications of office hysteroscopy: abnormal pre- or postmenopausal uterine bleeding; endometrial thickening or polyps; submucosal and some intramural fibroids; intrauterine adhesions; uterine malformations; retained intrauterine contraceptives or removal of foreign bodies. In cases of larger polyps > 2.5 cm, myoma type 0 > 1.5 cm and myoma type 1 and 2, participants were not eligible for office hysteroscopy or for this study.
The patients also needed to understand written Swedish to apprehend the study information and respond to the self-rated questionnaires. Exclusion criteria were viable intrauterine pregnancy, active pelvic infection (including genital herpes infection) or known cervical or uterine cancer, and poor ability to understand Swedish.
Consent and randomisation
Participants who accepted the invitation to participate signed a consent form and were randomly allocated to either the doula intervention or routine care. Based on week numbers (even/odd) when they were enrolled, the patients were alternated assigned to either of the two groups. The assignment was conducted by a medical secretary. To minimize bias based on patient expectations, allocation was not revealed to the patients (before the office hysteroscopy). They were informed about the scheduled time and place and received general information about the gynaecological procedure.
Office hysteroscopy procedure
The office hysteroscopy procedure and materials used during the procedure were identical in both groups, with the same experienced gynaecologist treating all patients. The standard appointment timeframe was 45 min. Patients were advised to take standard doses of Nonsteroidal anti-inflammatory drugs (NSAIDs)
(400 mg Ibuprofen) around 1 hour before their scheduled appointment.
Miniature hysteroscopies (CAMPO TROPHYSCOPE®) were used. All patients received local anaesthesia with a paracervical block of 6 ml of mepivacaine 10 mg/ml in the cervix.
The choice of distension was normal saline [12]. With the patient in a dorsal lithotomy position, a vaginoscopy without the use of a vaginal speculum and cervical tenaculum was performed. The hysteroscopy was connected to a camera and a monitor. Depending on the findings, the following procedures were performed as required: biopsies, polypectomies, or myomectomies, using the same hysteroscope.
Doula intervention group
A doula accompanied the participants throughout the procedure, starting from the moment the patient registered at the front desk and ending when they left the clinic. In line with the elements of doula support in the childbirth context [13], the doula in the present study aimed to provide: a) attention to physical comfort; b) emotional support (praise, reassurance, encouragement, and continuous presence); c) information sharing (nonmedical advice, explanation of policies and procedures, anticipatory guidance) and d) advocacy (facilitation of communication between the woman and hospital staff to assist in making informed decisions). The doula was qualified, had 12 years of experience as a doula, and was employed as an assistant nurse at the clinic. To avoid spill-over effects, she was not attending to patients in the control group.
Routine care control group
The control group received basic support from an assistant nurse during the office hysteroscopy and were provided a comfortable and safe environment with acoustic, thermal, and visual comfort. The basic support from the nurse assistant had the main focus to facilitate the gynaecological procedure. This was different from the doula support, which focused on the patient’s needs and participation.
Sample size
A total of 28 women were included, 12 in the Doula intervention group and 16 in the routine care group.
Outcomes
Background data were collected by the gynaecologist or a research assistant at the start of the appointment, including age, body mass index, the number of vaginal deliveries, educational achievement level, and history of endometrial surgery (curettage and/or hysteroscopy), diabetes, age, previous curettage, dyspareunia, severe dysmenorrhea, and previous hysteroscopy experience. Cervical stenosis was classified based on localization: stenosis of external cervical ostium (ECO; type I); stenosis of the distal third of cervical channel and the internal cervical ostium (ICO; type II); stenosis of the ICO (type III), and combined stenosis of ECO and ICO (type IV))[14]. Outcome data were collected at the start of the office hysteroscopy, and at different phases during the procedure. STAI-s post-procedure were collected in the same room immediately after the hysteroscopy.
Feasibility
Feasibility was evaluated by three outcomes:
1) Number of successful (access to and visualization of the entire uterine cavity was possible during the same procedure), partially successful (access to uterine cavity possible, but the entire uterine cavity could not be examined) or failed (access to uterine cavity was not possible) hysteroscopies.
2) Duration of the procedure.
3) Complications (bleedings, false tracks, uterine perforation or cervical tears, or reactions to mepivacain (numbness and tingling of the lips or tongue, nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, sweating, unconsciousness or respiratory arrest).
Anxiety
The Spielberg State-Trait Anxiety Inventory (STAI) was used to measure the patients’ anxiety before and after the office hysteroscopy [2,15–16]. The STAI is a widely used measure, validated among perinatal women, where it has shown acceptable sensitivity, specificity, and predictive validity [17]. The assessment consists of two subscales, the STAI-S (state anxiety) and the STAI-T (anxiety as a general trait). Each subscale has 20 items with each item rated using a 4-point Likert scale and a score >40 as the suggested cut off for clinically significant anxiety [18]. For this study, to minimize the time and number of questions asked to the participants, only the STAI-S was used to measure the situational anxiety pre- and post-procedure.
Pain
The Numeric Rating Scale (NRS), an instrument for self-reported pain intensity, was used. The patient reports a number between 0 and 10, where 10 stands for worst possible pain, 0 indicates no pain. The NRS is similar to the commonly used Visual Analog Scale (VAS) but is less influenced by non-pain intensity factors [19]. Pain intensity was assessed via NRS 0–10 at four points in time during the procedure:
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Introduction of hysteroscopy into the vagina.
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Progression through the cervical canal up to the internal uterine orifice.
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Inspection of the uterine cavity.
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Performance of the endometrial biopsy/polypectomy etc. if required.
Previous well-defined limits for unacceptable pain were used [20]. Pain was considered unacceptable if severe pain was reported during the procedure (NRS ≥7). In these cases, the office hysteroscopy was discontinued. The pain variable was also dichotomized, defined as >4 = moderate-to-severe pain [21].
Statistical analyses
The sample size was planned in line with the rule of thumb for pilot studies [22], suggesting 12 subjects in each group.
Descriptive statistics were used to describe the clinical and background variables. For the continuous variables pain (NRS) and anxiety (STAI-S), differences between groups were analysed using analysis of variance (ANOVA). Data for the STAI-S was approximately normally distributed according to histograms and Shapiro Wilk’s test of normality. The dichotomized pain variable (NRS) was analysed using the chi-square test. A p-value of ≤ 0.05 was set as the limit for statistical significance in all tests. IBM SPSS Statistics version 25.0 was used for all statistical analyses.
Ethical considerations
To minimize the risk of harm, the office hysteroscopy was discontinued if pain increased above predefined limits. All participants were informed that participation was voluntary and declining to or withdrawing from the study would not affect their treatment at the clinic. The study was approved by the Regional Ethics Review Board in Gothenburg, registration number 840-18.